Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-07 @ 10:08 AM
Study NCT ID:
NCT03034850
Status:
COMPLETED
Last Update Posted:
2017-01-27
First Post:
2017-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thrombin Generation and Platelet Activation in CRS/HIPEC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D011553', 'term': 'Pseudomyxoma Peritonei'}, {'id': 'D010534', 'term': 'Peritoneal Neoplasms'}], 'ancestors': [{'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D002288', 'term': 'Adenocarcinoma, Mucinous'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D018297', 'term': 'Neoplasms, Cystic, Mucinous, and Serous'}, {'id': 'D000008', 'term': 'Abdominal Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D007069', 'term': 'Ifosfamide'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-24', 'studyFirstSubmitDate': '2017-01-12', 'studyFirstSubmitQcDate': '2017-01-24', 'lastUpdatePostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood loss', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': 'Blood loss and administration of red blood cells, fresh frozen plasma and platelets. Blood loss is quantitatively assessed based on surgical drainage volume measurements, recorded every hour. Once the surgical drains are removed (average 7 days), blood loss is quantified by hemodynamic instability and abrupt, significant decrease of hemoglobin concentration. Blood loss is assessed from the date of CRS/HIPEC surgery until 7 days postoperative or date of death from any cause, whichever came first.'}], 'secondaryOutcomes': [{'measure': 'Red blood cell count', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': 'EDTA-anticoagulated blood was used for cytometric analysis using a whole blood counter Sysmex XE 2100® (Sysmex,Kobe, Japan) to obtain a whole blood count. (million cells/mcL)'}, {'measure': 'White blood cell count', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': 'EDTA-anticoagulated blood was used for cytometric analysis using a whole blood counter Sysmex XE 2100® (Sysmex,Kobe, Japan) to obtain a whole blood count. (cells/mcL)'}, {'measure': 'Platelet count', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': 'EDTA-anticoagulated blood was used for cytometric analysis using a whole blood counter Sysmex XE 2100® (Sysmex,Kobe, Japan) to obtain a whole blood count. (platelets/mcL)'}, {'measure': 'Fibrinogen levels', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': 'Fibrinogen levels were determined with an ACL-9000 (Diamond Diagnostics, Holliston, MA) coagulation analyser. (g/dL)'}, {'measure': 'Prothrombin Time (PT)', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': 'Prothrombin time was measured using an ACL-9000 coagulation analyser (sec).'}, {'measure': 'Activated Partial Thromboplastin Time (aPTT)', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': 'Activated Partial Thromboplastin Time was measured using an ACL-9000 coagulation analyser (sec).'}, {'measure': 'Endogenous Thrombin Potential (Thrombin generation assay (CAT))', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': 'TG in plasma, measured with the calibrated automated thrombogram (CAT) . Briefly, 80 μl platelet poor plasma (PPP) was mixed with 20 μl of a mixture containing tissue factor (Dade-Behring) at a final concentration of 1 pM and phospholipid vesicles (f.c. 4 μM 20 mol% phosphatidylserine, 60 mol% phosphatidylcholine and 20 mol% phosphatidyl-ethanolamine, Avanti). To calibrator wells, 20 μl of calibrator (α2macroglobulin- thrombin complex) was added instead of TF and PL. After 10 minutes of incubation at 37°C, thrombin generation was initiated by the addition of 20 μl of the thrombin specific substrate, Z- Gly-Gly-Arg-7-amino-4-methylcoumarin (f.c. 416 μM, Bachem) and CaCl2 (f.c. 16.7 mM). Fluorescence was measured with a Fluoroscan Ascent reader (Thermo Labsystems) and data were analyzed with dedicated software (Thrombinoscope, Stago) \\[20\\]. Endogenous thrombin potential (ETP) (nM\\*min)'}, {'measure': 'Lag Time (Thrombin generation assay (CAT))', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': 'TG in plasma, measured with the calibrated automated thrombogram (CAT) . Briefly, 80 μl platelet poor plasma (PPP) was mixed with 20 μl of a mixture containing tissue factor (Dade-Behring) at a final concentration of 1 pM and phospholipid vesicles (f.c. 4 μM 20 mol% phosphatidylserine, 60 mol% phosphatidylcholine and 20 mol% phosphatidyl-ethanolamine, Avanti). To calibrator wells, 20 μl of calibrator (α2macroglobulin- thrombin complex) was added instead of TF and PL. After 10 minutes of incubation at 37°C, thrombin generation was initiated by the addition of 20 μl of the thrombin specific substrate, Z- Gly-Gly-Arg-7-amino-4-methylcoumarin (f.c. 416 μM, Bachem) and CaCl2 (f.c. 16.7 mM). Fluorescence was measured with a Fluoroscan Ascent reader (Thermo Labsystems) and data were analyzed with dedicated software (Thrombinoscope, Stago) \\[20\\]. lagtime (LT)(min)'}, {'measure': 'Time-to-Thrombin Peak (Thrombin generation assay (CAT))', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': 'TG in plasma, measured with the calibrated automated thrombogram (CAT) . Briefly, 80 μl platelet poor plasma (PPP) was mixed with 20 μl of a mixture containing tissue factor (Dade-Behring) at a final concentration of 1 pM and phospholipid vesicles (f.c. 4 μM 20 mol% phosphatidylserine, 60 mol% phosphatidylcholine and 20 mol% phosphatidyl-ethanolamine, Avanti). To calibrator wells, 20 μl of calibrator (α2macroglobulin- thrombin complex) was added instead of TF and PL. After 10 minutes of incubation at 37°C, thrombin generation was initiated by the addition of 20 μl of the thrombin specific substrate, Z- Gly-Gly-Arg-7-amino-4-methylcoumarin (f.c. 416 μM, Bachem) and CaCl2 (f.c. 16.7 mM). Fluorescence was measured with a Fluoroscan Ascent reader (Thermo Labsystems) and data were analyzed with dedicated software (Thrombinoscope, Stago) \\[20\\]. Time-to-Thrombin Peak (TTP)(min)'}, {'measure': 'Thrombin Peak (TP) (Thrombin generation assay (CAT))', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': 'TG in plasma, measured with the calibrated automated thrombogram (CAT) . Briefly, 80 μl platelet poor plasma (PPP) was mixed with 20 μl of a mixture containing tissue factor (Dade-Behring) at a final concentration of 1 pM and phospholipid vesicles (f.c. 4 μM 20 mol% phosphatidylserine, 60 mol% phosphatidylcholine and 20 mol% phosphatidyl-ethanolamine, Avanti). To calibrator wells, 20 μl of calibrator (α2macroglobulin- thrombin complex) was added instead of TF and PL. After 10 minutes of incubation at 37°C, thrombin generation was initiated by the addition of 20 μl of the thrombin specific substrate, Z- Gly-Gly-Arg-7-amino-4-methylcoumarin (f.c. 416 μM, Bachem) and CaCl2 (f.c. 16.7 mM). Fluorescence was measured with a Fluoroscan Ascent reader (Thermo Labsystems) and data were analyzed with dedicated software (Thrombinoscope, Stago) \\[20\\]. Thrombin Peak (TP)(nM)'}, {'measure': 'P-selectin expression (Platelet activation test (PACT))', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': 'Platelet activation was quantitatively assessed in un-processed blood by the PACT (Platelet activation test). Addition of specific agonists to whole blood (granule release capacity and in the aggregation potential of platelets). (1) the protease activated receptor (PAR-1) agonist thrombin receptor activator peptide, (2) the glycoprotein VI (GPVI) agonist collagen-related peptide , and (3) the P2Y12 agonist ADP. The reaction mixtures also contain three antibodies directed against GPIb, activated αIIbβ3 and P-selectin. Flow cytometry was used to distinguish between platelets and other cells on forward and sideward scatter pattern and by gating on the CD42b positive cells. Fluorescent intensity in the FITC gate and PE gate was selected to determine activated αIIbβ3 and P-selectin density, respectively, and results are expressed as median fluorescent intensity (MFI). P-selectin expression(MFI, median fluorescent intensity)'}, {'measure': 'αIIbβ3 activation (Platelet activation test (PACT))', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': 'Platelet activation was quantitatively assessed in un-processed blood by the PACT (Platelet activation test). Addition of specific agonists to whole blood (granule release capacity and in the aggregation potential of platelets). (1) the protease activated receptor (PAR-1) agonist thrombin receptor activator peptide, (2) the glycoprotein VI (GPVI) agonist collagen-related peptide , and (3) the P2Y12 agonist ADP. The reaction mixtures also contain three antibodies directed against GPIb, activated αIIbβ3 and P-selectin. Flow cytometry was used to distinguish between platelets and other cells on forward and sideward scatter pattern and by gating on the CD42b positive cells. Fluorescent intensity in the FITC gate and PE gate was selected to determine activated αIIbβ3 and P-selectin density, respectively, and results are expressed as median fluorescent intensity (MFI). αIIbβ3 activation (MFI, median fluorescent intensity)'}, {'measure': 'A5 EXTEM (Rotational thromboelastometry (ROTEM))', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': "Thrombus formation was measured by ROTEM (Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). Standard assays were used according to the manufacturer's recommendations: EXTEM (ref.: 503-05, Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands), A5: amplitude of clot firmness 5 min after CT (mm)"}, {'measure': 'A5 FIBTEM (Rotational thromboelastometry (ROTEM))', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': "Thrombus formation was measured by ROTEM (Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). Standard assays were used according to the manufacturer's recommendations: FIBTEM (ref.: 503-06, Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands), All samples were measured within 1 h after blood collection. A5: amplitude of clot firmness 5 min after CT (mm)"}, {'measure': 'A5 HEPTEM (Rotational thromboelastometry (ROTEM))', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': "Thrombus formation was measured by ROTEM (Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). Standard assays were used according to the manufacturer's recommendations: HEPTEM (ref.: 503-09, Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). All samples were measured within 1 h after blood collection. A5: amplitude of clot firmness 5 min after CT (mm)"}, {'measure': 'A30 EXTEM (Rotational thromboelastometry (ROTEM))', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': "Thrombus formation was measured by ROTEM (Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). Standard assays were used according to the manufacturer's recommendations: EXTEM (ref.: 503-05, Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). All samples were measured within 1 h after blood collection. A30: amplitude of clot firmness 30 min after CT (mm)"}, {'measure': 'A30 FIBTEM (Rotational thromboelastometry (ROTEM))', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': "Thrombus formation was measured by ROTEM (Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). Standard assays were used according to the manufacturer's recommendations: FIBTEM (ref.: 503-06, Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). All samples were measured within 1 h after blood collection. A30: amplitude of clot firmness 30 min after CT (mm)"}, {'measure': 'A30 HEPTEM (Rotational thromboelastometry (ROTEM))', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': "Thrombus formation was measured by ROTEM (Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). Standard assays were used according to the manufacturer's recommendations: HEPTEM (ref.: 503-09, Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). All samples were measured within 1 h after blood collection. A30: amplitude of clot firmness 30 min after CT (mm)"}, {'measure': 'Alpha EXTEM (Rotational thromboelastometry (ROTEM))', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': "Thrombus formation was measured by ROTEM (Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). Standard assays were used according to the manufacturer's recommendations: EXTEM (ref.: 503-05, Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). All samples were measured within 1 h after blood collection. Alpha (the angle between the baseline and a tangent to the clotting curve through the 2 mm point; degree)"}, {'measure': 'Alpha FIBTEM (Rotational thromboelastometry (ROTEM))', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': "Thrombus formation was measured by ROTEM (Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). Standard assays were used according to the manufacturer's recommendations: FIBTEM (ref.: 503-06, Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). All samples were measured within 1 h after blood collection. Alpha (the angle between the baseline and a tangent to the clotting curve through the 2 mm point; degree)"}, {'measure': 'Alpha HEPTEM (Rotational thromboelastometry (ROTEM))', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': "Thrombus formation was measured by ROTEM (Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). Standard assays were used according to the manufacturer's recommendations: HEPTEM (ref.: 503-09, Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). All samples were measured within 1 h after blood collection. Alpha (the angle between the baseline and a tangent to the clotting curve through the 2 mm point; degree)"}, {'measure': 'Coagulation Time CT EXTEM (Rotational thromboelastometry (ROTEM))', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': "Thrombus formation was measured by ROTEM (Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). Standard assays were used according to the manufacturer's recommendations: EXTEM (ref.: 503-05, Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). All samples were measured within 1 h after blood collection. Coagulation Time (CT): test start until a clot firmness amplitude of 2 mm is reached; sec."}, {'measure': 'Coagulation Time CT FIBTEM (Rotational thromboelastometry (ROTEM))', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': "Thrombus formation was measured by ROTEM (Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). Standard assays were used according to the manufacturer's recommendations: FIBTEM (ref.: 503-06, Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands), All samples were measured within 1 h after blood collection. Coagulation Time (CT): test start until a clot firmness amplitude of 2 mm is reached; sec."}, {'measure': 'Coagulation Time CT HEPTEM (Rotational thromboelastometry (ROTEM))', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': "Thrombus formation was measured by ROTEM (Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). Standard assays were used according to the manufacturer's recommendations: HEPTEM (ref.: 503-09, Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). All samples were measured within 1 h after blood collection. Coagulation Time (CT): test start until a clot firmness amplitude of 2 mm is reached; sec."}, {'measure': 'Clot Formation Time CFT EXTEM (Rotational thromboelastometry (ROTEM)', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': "Thrombus formation was measured by ROTEM (Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). Standard assays were used according to the manufacturer's recommendations: EXTEM (ref.: 503-05, Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands), All samples were measured within 1 h after blood collection. CFT: in seconds indicates the time between 2 and 20 mm clot firmness amplitude is achieved (sec)"}, {'measure': 'Clot Formation Time CFT FIBTEM (Rotational thromboelastometry (ROTEM)', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': "Thrombus formation was measured by ROTEM (Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). Standard assays were used according to the manufacturer's recommendations: FIBTEM (ref.: 503-06, Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). All samples were measured within 1 h after blood collection. CFT: in seconds indicates the time between 2 and 20 mm clot firmness amplitude is achieved (sec)"}, {'measure': 'Clot Formation Time CFT HEPTEM (Rotational thromboelastometry (ROTEM)', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': "Thrombus formation was measured by ROTEM (Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). Standard assays were used according to the manufacturer's recommendations: HEPTEM (ref.: 503-09, Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). All samples were measured within 1 h after blood collection. CFT: in seconds indicates the time between 2 and 20 mm clot firmness amplitude is achieved (sec)"}, {'measure': 'Maximum Lysis (ML) EXTEM Rotational thromboelastometry (ROTEM)', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': "Thrombus formation was measured by ROTEM (Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). Standard assays were used according to the manufacturer's recommendations: EXTEM (ref.: 503-05, Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). All samples were measured within 1 h after blood collection. Maximum Lysis (ML; %): maximum lysis during runtime"}, {'measure': 'Maximum Lysis (ML) FIBTEM Rotational thromboelastometry (ROTEM)', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': "Thrombus formation was measured by ROTEM (Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). Standard assays were used according to the manufacturer's recommendations: FIBTEM (ref.: 503-06, Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). All samples were measured within 1 h after blood collection. Maximum Lysis (ML; %): maximum lysis during runtime"}, {'measure': 'Maximum Lysis (ML) HEPTEM Rotational thromboelastometry (ROTEM)', 'timeFrame': 'From surgical incision to 7 days postoperative', 'description': "Thrombus formation was measured by ROTEM (Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). Standard assays were used according to the manufacturer's recommendations: HEPTEM (ref.: 503-09, Tem International GmbH c/o Dutch Affiliate, Tilburg, The Netherlands). Maximum Lysis (ML; %): maximum lysis during runtime"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cytoreductive surgery', 'hyperthermic intraperitoneal peroperative chemotherapy', 'platelet function', 'thrombin generation', 'thromboelastometry'], 'conditions': ['Mesothelioma; Peritoneum', 'Pseudomyxoma Peritonei', 'Peritoneal Carcinomatosis']}, 'referencesModule': {'availIpds': [{'url': 'https://drive.google.com/open?id=0B0qo2hDQpXhncWZFZkNfZXhZMjVuUGcxc0IzZll5TEtjaXdn', 'type': 'Study Protocol'}, {'id': 'eudract/B-nr B37120154199', 'url': 'https://drive.google.com/open?id=0B0qo2hDQpXhnU3AzRHY0d1NtVmlsSmx1cFhKOGtKLTVscno0', 'type': 'Advice Ethical Committee'}], 'references': [{'pmid': '7826158', 'type': 'BACKGROUND', 'citation': 'Sugarbaker PH. Peritonectomy procedures. Ann Surg. 1995 Jan;221(1):29-42. doi: 10.1097/00000658-199501000-00004.'}, {'pmid': '11641098', 'type': 'BACKGROUND', 'citation': 'Elias DM, Ouellet JF. 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Cancer Chemother Pharmacol. 2013 Mar;71(3):693-704. doi: 10.1007/s00280-012-2060-2. Epub 2012 Dec 30.'}, {'pmid': '18336490', 'type': 'BACKGROUND', 'citation': 'Schmidt C, Creutzenberg M, Piso P, Hobbhahn J, Bucher M. Peri-operative anaesthetic management of cytoreductive surgery with hyperthermic intraperitoneal chemotherapy. Anaesthesia. 2008 Apr;63(4):389-95. doi: 10.1111/j.1365-2044.2007.05380.x.'}, {'pmid': '25319432', 'type': 'BACKGROUND', 'citation': 'Desantis M, Bernard JL, Casanova V, Cegarra-Escolano M, Benizri E, Rahili AM, Benchimol D, Bereder JM. Morbidity, mortality, and oncological outcomes of 401 consecutive cytoreductive procedures with hyperthermic intraperitoneal chemotherapy (HIPEC). Langenbecks Arch Surg. 2015 Jan;400(1):37-48. doi: 10.1007/s00423-014-1253-z. Epub 2014 Oct 16.'}, {'pmid': '24886171', 'type': 'BACKGROUND', 'citation': 'Kajdi ME, Beck-Schimmer B, Held U, Kofmehl R, Lehmann K, Ganter MT. Anaesthesia in patients undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy: retrospective analysis of a single centre three-year experience. World J Surg Oncol. 2014 May 1;12:136. doi: 10.1186/1477-7819-12-136.'}, {'pmid': '22805865', 'type': 'BACKGROUND', 'citation': 'Bell JC, Rylah BG, Chambers RW, Peet H, Mohamed F, Moran BJ. Perioperative management of patients undergoing cytoreductive surgery combined with heated intraperitoneal chemotherapy for peritoneal surface malignancy: a multi-institutional experience. Ann Surg Oncol. 2012 Dec;19(13):4244-51. doi: 10.1245/s10434-012-2496-y. Epub 2012 Jul 18.'}, {'pmid': '22182345', 'type': 'BACKGROUND', 'citation': 'Cooksley TJ, Haji-Michael P. Post-operative critical care management of patients undergoing cytoreductive surgery and heated intraperitoneal chemotherapy (HIPEC). 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Blood Coagul Fibrinolysis. 2015 Sep;26(6):613-20. doi: 10.1097/MBC.0000000000000307.'}], 'seeAlsoLinks': [{'url': 'http://www.cancercenter.com/treatments/hipec/', 'label': 'Hyperthermic intraperitoneal chemotherapy'}]}, 'descriptionModule': {'briefSummary': 'Cytoreductive surgery (CRS) with hyperthermic intraperitoneal peroperative chemotherapy (HIPEC), indicated for patients with peritoneal metastases from digestive or gynecological malignancies alike, demonstrates a considerable impact on hemostatic metabolism, both on platelet and on coagulation level. The potential hemostatic interference in CRS and HIPEC is phase dependent. This study demonstrates the combined use of ROTEM (rotational thromboelastometry), PACT (platelet activation test) and CAT (thrombin generation test) assays during CRS and HIPEC with a follow-up of 7 days postoperative.', 'detailedDescription': 'The purpose of this study was to quantitatively assess the impact of CRS and HIPEC, on various components of hemostasis. Routine laboratory assays such as activated clotting time, activated partial thromboplastin time, prothrombin time, or platelet count might, as demonstrated previously, insufficiently provide specificity and/or sensitivity to assess coagulation and platelet disorders. Therefore, additionally thrombin generation (TG) was analyzed by the calibrated automated thrombogram assay (CAT). Also, platelet function was quantitatively assessed by the PAC-t-UB assay and rotational thromboelastometry (ROTEM) was used to elucidate the contribution of platelets, intrinsic and extrinsic coagulation pathways in peri-operative bleeding. The hypothesis of this study was that the procedure exposed an increased thrombotic risk, resulting in a faster and increased TG and hyper platelet function?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This prospective observational pilot study, scheduled between April 2015 and July 2016, included 27 patients from the Ziekenhuis Oost-Limburg, Genk, Belgium, after approval by the local medical ethics committee (Eudract/B nr: B371201524199) and written informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a confirmed histological diagnosis of peritoneal disease (e.g., mesothelioma; pseudomyxoma peritonei; colorectal, ovarian, or gastric peritoneal carcinomatosis of colorectal, ovarian, or gastric cancer origin; or abdominal sarcomatosis); and\n* age \\<80 years; and\n* a cardiac, renal, hepatic, and bone marrow function compatible with surgery; and\n* informed written consent to participate in the study\n\nExclusion Criteria:(or)\n\n* inherited coagulation abnormalities,\n* active systemic infections,\n* interstitial lung disease,\n* serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure, uncontrolled hypertension (diastolic blood pressure constantly \\>100 mm Hg, systolic blood pressure constantly \\> 180 mm Hg).\n* inadequate bone marrow function at the beginning of the trial, defined as platelet count less than \\<150 GPT/L or neutrophil granulocyte count less than \\<1.5 GPT/L.\n* inadequate renal function at the beginning of the trial, defined as GFR less than \\<60 ml/min,\n* inadequate liver function at the beginning of the trial, defined as bilirubin \\>1.5 times ULN (upper limit of normal), active hepatitis B or C infection,\n* female patients who are pregnant or breast feeding\n* participation in another therapeutic clinical trial.'}, 'identificationModule': {'nctId': 'NCT03034850', 'briefTitle': 'Thrombin Generation and Platelet Activation in CRS/HIPEC', 'organization': {'class': 'OTHER', 'fullName': 'Ziekenhuis Oost-Limburg'}, 'officialTitle': 'Thrombin Generation and Platelet Activation in Cytoreductive Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy', 'orgStudyIdInfo': {'id': 'B37120154199'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CRS/HIPEC', 'description': 'Patients with a confirmed histological diagnosis of peritoneal disease treated by cytoreductive surgery (CRS) with hyperthermic intraperitoneal peroperative chemotherapy (HIPEC).', 'interventionNames': ['Procedure: CRS/HIPEC']}], 'interventions': [{'name': 'CRS/HIPEC', 'type': 'PROCEDURE', 'otherNames': ['oxaliplatinum', '5-fluorouracil', 'folinic acid', 'cisplatinum', 'doxorubicin', 'ifosfamide'], 'description': 'The generic surgical approach involved peritonectomy procedures and visceral resections called CRS as described by Sugarbaker (1995). Peritoneal disease burden was assessed using the perito- neal cancer index (PCI), which scores 13 intra-abdominal sites on a scale of 0 (no disease) to 3 (lesion size \\> 5 cm), thus giving a range of possible scores from 0 to 39. The same team performed the surgical procedure of all included patients. Before connection to the patient, the circuit was filled with dextrose 5% (2 L/m2 body surface area) and warmed to 37°C.', 'armGroupLabels': ['CRS/HIPEC']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sven Van Poucke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziekenhuis Oost-Limburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'All de-identified data will be available 6 months after inclusion of the last patient by contacting the principle investigator (svanpoucke@gmail.com). Once the results of the study are available and published, all data will be part of the publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziekenhuis Oost-Limburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Anesthesiologist, Emergency Physician', 'investigatorFullName': 'Sven Van Poucke', 'investigatorAffiliation': 'Ziekenhuis Oost-Limburg'}}}}