Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-03-04 @ 10:24 PM
Study NCT ID:
NCT02153593
Status:
TERMINATED
Last Update Posted:
2016-09-20
First Post:
2014-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Bleeding Prevention in Massive Bone Tumour Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D001859', 'term': 'Bone Neoplasms'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D015718', 'term': 'Fibrin Tissue Adhesive'}, {'id': 'D003972', 'term': 'Diathermy'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005337', 'term': 'Fibrin'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'whyStopped': 'Difficulty in recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-19', 'studyFirstSubmitDate': '2014-05-27', 'studyFirstSubmitQcDate': '2014-06-02', 'lastUpdatePostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total blood loss (mL) in the postoperative period', 'timeFrame': 'The first postoperative 48h', 'description': 'The blood loss will be collected by the drainage system and quantified in mL.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients requiring blood transfusion', 'timeFrame': 'The first postoperative 2 weeks'}, {'measure': 'Units of blood transfused', 'timeFrame': 'The first postoperative 2 weeks'}, {'measure': 'Proportion of patients with wound infection', 'timeFrame': 'The first postoperative month'}, {'measure': 'Proportion of patients with wound dehiscence', 'timeFrame': 'The first postoperative month'}, {'measure': 'Proportion of patients with reoperation for wound complications', 'timeFrame': 'The first postoperative month'}, {'measure': 'Deep venous thrombosis', 'timeFrame': 'The first postoperative 2 weeks'}, {'measure': 'Proportion of patients with seroma', 'timeFrame': 'The first postoperative month'}, {'measure': 'Postoperative pain related with the surgery', 'timeFrame': 'The first postoperative week'}, {'measure': 'Tumoral local relapse rate', 'timeFrame': 'The first postoperative month'}, {'measure': 'Tumoral systemic dissemination rate', 'timeFrame': 'The first postoperative month'}, {'measure': 'Mortality', 'timeFrame': 'The first postoperative month'}, {'measure': 'Proportion of patients in which chemotherapy is delayed for wound complications', 'timeFrame': 'The first postoperative month'}, {'measure': 'Proportion of patients in which radiotherapy is delayed for wound complications.', 'timeFrame': 'The first postoperative month'}, {'measure': 'Length of hospital stay', 'timeFrame': 'The first postoperative 2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Clinical trial', 'Randomized', 'Fibrin glue', 'Tranexamic acid', 'Blood loss'], 'conditions': ['Blood Loss', 'Bone Tumour']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Ibáñez AP, Martinez-Zapata MJ, Tarragó LT, Balaguer MB, Roig XA, Joy IG, Areizaga L, Merino J, Alcalá R, Tranextum Study Group. Postoperative bleeding prevention in massive bone tumour resection: a multicentric, randomized, parallel, controlled trial to assess the efficacy of tranexamic acid versus Evicel and usual haemostasis [protocol]. Basic and Clinical Pharmacology. 2014; 115 (Suppl 3): 20-21.'}]}, 'descriptionModule': {'briefSummary': 'Massive bone tumour resection is often associated with important postoperative bleeding. This may determine systemic (anaemia), as well as local complications (wound healing, seroma, haematoma).\n\nThe objective of this study is to determine whether the use of topical tranexamic acid or topical Evicel® will reduce the perioperative bleeding comparing it with usual haemostasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years and older\n* Musculoskeletal tumor (primary or metastatic, benign or malignant) located in extremities, shoulder girdle or pelvis.\n* Massive or bloc tumour resection.\n* Patient's consent to participate\n\nExclusion Criteria:\n\n* Known allergy to ATX\n* Allergy or known hypersensitivity to bovine proteins (aprotinin)\n* Liposarcomas low grade\n* History of thromboembolic disease or prothrombotic conditions:\n\n * cerebral vascular accident\n * ischemic heart disease\n * deep and / or superficial vein thrombosis\n * pulmonary embolism\n * peripheral arterial vasculopathy\n * thrombogenic arrhythmias (eg: ACxFA)\n * patients with cardiovascular stents\n * prothrombotic alterations in coagulation\n* Treatment with contraceptive drugs"}, 'identificationModule': {'nctId': 'NCT02153593', 'acronym': 'TRANEXTUM', 'briefTitle': 'Postoperative Bleeding Prevention in Massive Bone Tumour Resection', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Postoperative Bleeding Prevention in Massive Bone Tumour Resection: a Multicentric, Randomized, Parallel, Controlled Trial to Assess the Efficacy of Tranexamic Acid Versus Evicel® and Usual Haemostasis', 'orgStudyIdInfo': {'id': 'IIBSP-EVI-2011-138'}, 'secondaryIdInfos': [{'id': 'EC11-340', 'type': 'OTHER_GRANT', 'domain': 'Ministry of Health and Social Policy 2011'}, {'id': '2011-006276-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tranexamic acid', 'description': 'Tranexamic acid, 1g intra-articular before closing the surgery wound', 'interventionNames': ['Drug: Tranexamic Acid', 'Procedure: Electrocauterization']}, {'type': 'EXPERIMENTAL', 'label': 'Fibrin glue', 'description': 'One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery', 'interventionNames': ['Drug: Fibrin glue', 'Procedure: Electrocauterization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual hemostasia', 'description': 'Electrocauterization', 'interventionNames': ['Procedure: Electrocauterization']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'otherNames': ['Amchafibrin'], 'description': '1g intra-articular before closing the wound surgery', 'armGroupLabels': ['Tranexamic acid']}, {'name': 'Fibrin glue', 'type': 'DRUG', 'otherNames': ['Evicel'], 'description': '5mL intra-articular before closing the wound surgery', 'armGroupLabels': ['Fibrin glue']}, {'name': 'Electrocauterization', 'type': 'PROCEDURE', 'description': 'Coagulation blood from vessels by means of a electrocautery', 'armGroupLabels': ['Fibrin glue', 'Tranexamic acid', 'Usual hemostasia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03550', 'city': 'Alicante', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital Universitario de San Juan de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '08025', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '48903', 'city': 'Barakaldo', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital Universitario de Cruces', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}], 'overallOfficials': [{'name': 'Ana Peiró, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}