Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-02-25 @ 5:39 PM
Study NCT ID:
NCT03784794
Status:
COMPLETED
Last Update Posted:
2021-06-08
First Post:
2018-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Blood Management for Massive Obstetric Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}, {'id': 'D004211', 'term': 'Disseminated Intravascular Coagulation'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D019851', 'term': 'Thrombophilia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013916', 'term': 'Thrombelastography'}, {'id': 'D001780', 'term': 'Blood Coagulation Tests'}, {'id': 'D005340', 'term': 'Fibrinogen'}, {'id': 'C025667', 'term': 'prothrombin complex concentrates'}, {'id': 'D010976', 'term': 'Platelet Count'}, {'id': 'D004906', 'term': 'Erythrocyte Count'}], 'ancestors': [{'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000209', 'term': 'Acute-Phase Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D001772', 'term': 'Blood Cell Count'}, {'id': 'D002452', 'term': 'Cell Count'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D010979', 'term': 'Platelet Function Tests'}, {'id': 'D002468', 'term': 'Cell Physiological Phenomena'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group A Fibrinogen Concentrate, Protrombin Complex Concentrate, trhromboelastometry guided Group B Cryoprecipitates, fresh frozen plasma, standard coagulation lab test'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-06', 'studyFirstSubmitDate': '2018-12-14', 'studyFirstSubmitQcDate': '2018-12-19', 'lastUpdatePostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Blood products transfused', 'timeFrame': '24 hrs', 'description': 'Number of allogeneic blood products transfused intra-op, within 24h after screening and in-hospital (RBC, Platelets and FFP; separate and overall)'}], 'secondaryOutcomes': [{'measure': 'Number of hemocomponents or fibrinogen concentrates needed to treat hypofibrinogenemia', 'timeFrame': 'day 0 to day 15', 'description': 'Number of packs of Cryo (pack of 5 \\~ 1 G Fibrinogen), Fibrinogen Concentrate (G), and PCC (500 UI) administered intra-operating'}, {'measure': 'Incidence of Red Blood Cells transfusion (RBC)', 'timeFrame': 'day 0 to day 15', 'description': 'Incidence ≥ 5 U RBC transfused'}, {'measure': 'Incidence of Massive Red Blood Cells transfusion (RBC)', 'timeFrame': 'day 0 to day 15', 'description': 'Incidence ≥ 10 U RBC transfused (first 24h after screening)'}, {'measure': 'estimated blood loss', 'timeFrame': 'day 0 to day 15', 'description': 'Overall estimated blood loss (EBL, ML)'}, {'measure': 'Time to bleeding control', 'timeFrame': '24 hrs', 'description': 'time from study entry to last hemostatic intervention/transfusion'}, {'measure': 'Incidence of coagulopathy', 'timeFrame': 'day 0 to day 15', 'description': 'detected by thromboelastometry or standard coagulation laboratory tests'}, {'measure': 'Incidence of hysterectomy', 'timeFrame': 'day 0 to day 15', 'description': 'number of obstetric hysterectomy for bleeding control'}, {'measure': 'Incidence of re-surgery', 'timeFrame': 'day 0 to day 15', 'description': 'number of procedures necessary for bleeding control'}, {'measure': 'Incidence of Transfused associated circulatory overload', 'timeFrame': 'day 0 to day 15', 'description': 'number of patients with transfused associated circulatory overload'}, {'measure': 'Incidence of surgical site infection or sepsis', 'timeFrame': 'day 0 to day 15', 'description': 'number of patients that developed health care related infections or sepsis'}, {'measure': 'Incidence of ICU admission', 'timeFrame': 'day 0 to day 15', 'description': 'number of patients that require admission to the ICU for complications related to hipovolemic shock'}, {'measure': 'In-hospital mortality', 'timeFrame': 'day 0 to day 15', 'description': 'number of deaths'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post Partum Hemorrhage', 'Massive tranfusion', 'Thromboelastometry'], 'conditions': ['Post Partum Hemorrhage', 'Fibrinogenolysis; Hemorrhage', 'Fibrinogen; Deficiency, Acquired', 'Massive Hemorrhage', 'Transfusion Related Complication']}, 'referencesModule': {'references': [{'pmid': '25289791', 'type': 'BACKGROUND', 'citation': 'Mallaiah S, Barclay P, Harrod I, Chevannes C, Bhalla A. Introduction of an algorithm for ROTEM-guided fibrinogen concentrate administration in major obstetric haemorrhage. Anaesthesia. 2015 Feb;70(2):166-75. doi: 10.1111/anae.12859. Epub 2014 Oct 7.'}, {'pmid': '25959192', 'type': 'BACKGROUND', 'citation': 'Mallaiah S, Chevannes C, McNamara H, Barclay P. A reply. Anaesthesia. 2015 Jun;70(6):760-1. doi: 10.1111/anae.13128. No abstract available.'}, {'pmid': '28969312', 'type': 'BACKGROUND', 'citation': 'Collins PW, Cannings-John R, Bruynseels D, Mallaiah S, Dick J, Elton C, Weeks AD, Sanders J, Aawar N, Townson J, Hood K, Hall JE, Collis RE. Viscoelastometric-guided early fibrinogen concentrate replacement during postpartum haemorrhage: OBS2, a double-blind randomized controlled trial. Br J Anaesth. 2017 Sep 1;119(3):411-421. doi: 10.1093/bja/aex181.'}, {'pmid': '25586727', 'type': 'BACKGROUND', 'citation': 'Wikkelso AJ, Edwards HM, Afshari A, Stensballe J, Langhoff-Roos J, Albrechtsen C, Ekelund K, Hanke G, Secher EL, Sharif HF, Pedersen LM, Troelstrup A, Lauenborg J, Mitchell AU, Fuhrmann L, Svare J, Madsen MG, Bodker B, Moller AM; FIB-PPH trial group. Pre-emptive treatment with fibrinogen concentrate for postpartum haemorrhage: randomized controlled trial. Br J Anaesth. 2015 Apr;114(4):623-33. doi: 10.1093/bja/aeu444. Epub 2015 Jan 13.'}, {'pmid': '29121548', 'type': 'BACKGROUND', 'citation': 'Snegovskikh D, Souza D, Walton Z, Dai F, Rachler R, Garay A, Snegovskikh VV, Braveman FR, Norwitz ER. Point-of-care viscoelastic testing improves the outcome of pregnancies complicated by severe postpartum hemorrhage. J Clin Anesth. 2018 Feb;44:50-56. doi: 10.1016/j.jclinane.2017.10.003. Epub 2017 Nov 7.'}, {'pmid': '24630470', 'type': 'BACKGROUND', 'citation': 'Olde Engberink RH, Kuiper GJ, Wetzels RJ, Nelemans PJ, Lance MD, Beckers EA, Henskens YM. Rapid and correct prediction of thrombocytopenia and hypofibrinogenemia with rotational thromboelastometry in cardiac surgery. J Cardiothorac Vasc Anesth. 2014 Apr;28(2):210-6. doi: 10.1053/j.jvca.2013.12.004.'}, {'pmid': '24065728', 'type': 'BACKGROUND', 'citation': 'Song JG, Jeong SM, Jun IG, Lee HM, Hwang GS. Five-minute parameter of thromboelastometry is sufficient to detect thrombocytopenia and hypofibrinogenaemia in patients undergoing liver transplantation. Br J Anaesth. 2014 Feb;112(2):290-7. doi: 10.1093/bja/aet325. Epub 2013 Sep 24.'}, {'pmid': '25024304', 'type': 'BACKGROUND', 'citation': 'Collins PW, Lilley G, Bruynseels D, Laurent DB, Cannings-John R, Precious E, Hamlyn V, Sanders J, Alikhan R, Rayment R, Rees A, Kaye A, Hall JE, Paranjothy S, Weeks A, Collis RE. Fibrin-based clot formation as an early and rapid biomarker for progression of postpartum hemorrhage: a prospective study. Blood. 2014 Sep 11;124(11):1727-36. doi: 10.1182/blood-2014-04-567891. Epub 2014 Jul 14.'}, {'pmid': '25888032', 'type': 'BACKGROUND', 'citation': 'Hagemo JS, Christiaans SC, Stanworth SJ, Brohi K, Johansson PI, Goslings JC, Naess PA, Gaarder C. Detection of acute traumatic coagulopathy and massive transfusion requirements by means of rotational thromboelastometry: an international prospective validation study. Crit Care. 2015 Mar 23;19(1):97. doi: 10.1186/s13054-015-0823-y.'}, {'pmid': '29794847', 'type': 'BACKGROUND', 'citation': 'Baksaas-Aasen K, Van Dieren S, Balvers K, Juffermans NP, Naess PA, Rourke C, Eaglestone S, Ostrowski SR, Stensballe J, Stanworth S, Maegele M, Goslings JC, Johansson PI, Brohi K, Gaarder C; TACTIC/INTRN collaborators. Data-driven Development of ROTEM and TEG Algorithms for the Management of Trauma Hemorrhage: A Prospective Observational Multicenter Study. Ann Surg. 2019 Dec;270(6):1178-1185. doi: 10.1097/SLA.0000000000002825.'}, {'pmid': '26296822', 'type': 'BACKGROUND', 'citation': 'Mace H, Lightfoot N, McCluskey S, Selby R, Roy D, Timoumi T, Karkouti K. Validity of Thromboelastometry for Rapid Assessment of Fibrinogen Levels in Heparinized Samples During Cardiac Surgery: A Retrospective, Single-center, Observational Study. J Cardiothorac Vasc Anesth. 2016 Jan;30(1):90-5. doi: 10.1053/j.jvca.2015.04.030. Epub 2015 May 5.'}, {'pmid': '26591047', 'type': 'RESULT', 'citation': 'Perez-Calatayud AA, Briones-Garduno JC, Rojas-Arellano ML. [Use of thromboelastography and thromboelastometry for the rational and opportune transfusion of hemoderivatives in obstetric hemorrhage]. Ginecol Obstet Mex. 2015 Sep;83(9):569-77. Spanish.'}]}, 'descriptionModule': {'briefSummary': 'Obstetric Hemorrhage continues to be the first cause of maternal morbidity and mortality around the world especially in middle to low income countriesThe blood components are high value resources; however, its use has been shown to be a risk factor of known complications. The aim of the study is to compare two algorithms of coagulation management in massive obstetric hemorrhage Methods A randomized prospective trial single center two arms study in patients with severe obstetric hemorrhage (PPH \\> 1000) 2 different transfusion protocols one guided by thromboelastometry and hemostatic drugs (protrombine complex concentrate and fibrinogen concentrate) and the second guided by standard coagulation test and hemocomponents. Sample is calculated to known variance, Analyses are intention-to-treat without imputation, with outcomes will be performed between groups using mixed-effects two level regression models. For binary outcomes, a logistic model will be used and results presented as adjusted odds ratios (ORs) alongside 95% confidence intervals (CIs). Count data will be analysed using Poisson multilevel or negative binomial models.\n\nPrimary Outcome Parameter:\n\nCompare between the two protocols:\n\nNumber of allogeneic blood products transfused intra-op, within 24h after screening and in-hospital (RBC, Platelets and FFP; separate and overall)\n\nSecondary Outcome Parameter:\n\nAnalysis of mortality, lenth of stay admission to the ICU, hysterectomy surgical reintervencion, Transfuse associated circulatory overload, Transfusion associated Acute lung injury, health associated infection will be measured as secondary outcome.', 'detailedDescription': 'Introduction Obstetric Hemorrhage continues to be the first cause of maternal morbidity and mortality around the world especially in middle to low income countries. Copying trauma transfusion therapies now a days algorithms have been developing for 2.1.1 transfusion in massive obstetric hemorrhage. Blood products, play an essential role in the management of these patients, either during resuscitation or definitive treatment. Early transfusion, defined as that required in the first 24 hours after admission, it is required in about 5% that enters the hospital and about 3% comes to require massive transfusion. The blood components are high value resources; however, its use has been shown to be a risk factor for infectious transfusion related immunomodulation, and noninfectious complications (TRALI, TACO), development of systemic inflammatory response, multiple organ failure and death. A liberal transfusion policy can further introduce the risk of a patient who is already committed.\n\nPatient blood management is an evidence-based, multidisciplinary approach to optimizing the care of patients who might need transfusion. PBM encompasses all aspects of patient evaluation and clinical management surrounding the transfusion decision-making process, including the application of appropriate indications, as well as minimization of blood loss and optimization of patient red cell mass.\n\nThe aim of the study is to compare two algorithms of coagulation management in massive obstetric hemorrhage Methods A randomized prospective trial single center two arms study in patients with severe obstetric hemorrhage (PPH \\> 1000) 2 different transfusion protocols one guided by thromboelastometry and hemostatic drugs (protrombine complex concentrate and fibrinogen concentrate) and the second guided by standard coagulation test and hemocomponents.\n\nRandomization for the patients will be made for every obstetric patient that enters the obstetric ward for attention of partum, and will be asked to sign consent, and the patients will be selected for each group of the study. Only does that have severe PPH will be entering the protocol with the algorithm for management previously selected. Demographic caracteristics will include Ethnicity, Body weight (KG), body height (CM) and BMI at hospital admission, Previous deliveries, Previous Caesarean section, Pre-eclampsia during pregnancy, History of obstetric hemorrhage, History of other kind of hemorrhage, Onset of labor (spontaneous, induced, no labor) Multiple gestation (singleton, twins, triplet) Reported cause of obstetric hemorrhage (placenta previa, placenta accreta, placenta abruption, retained placenta, uterine atony, trauma, surgical bleeding Mode of delivery (spontaneous vaginal, instrumental vaginal , elective Caesarean section, non-elective Caesarean section) Baseline Hb, Hct, Plt count, Fibrinogen (Clauss), PT/INR, PTT (at hospital admission) Estimated blood loss at study entry (ML).\n\nTreatment algorithms are evidence based and the management of coagulopathy is based on treat first what kills fist (ATLS proposal)\n\nGroup A:\n\nTHROMBOELASTOMETRY-GUIDED ALGORITHM FIBRINOGEN CONCENTRATE FIBTEM A5 \\< 12 MM AND EXTEM A5 \\< 40 MM FIBTEM A5 = 9-11 MM → 2 G FIBRINOGEN CONC. (25 MG/KG); FIBTEM A5 = 4-8 MM → 4 G FIBRINOGEN CONC. (50 MG/KG); FIBTEM A5 \\< 4 MM → 6 G FIBRINOGEN CONC. (75 MG/KG) GOAL: FIBTEM A5: 12-16 MM PLATELETS EXTEM A5 \\< 40 MM AND FIBTEM A5 ≥ 12 MM EXTEM A5 \\< 40 MM → 1 PLATELET POOL OR APHERESIS; EXTEM A5 \\< 30 MM → 2 PLATELET POOL OR APHERESIS GOAL: EXTEM A5: 40-50 MM PROTROMBIN COMPLEX CONCENTRATE EXTEM CT \\> 80 SEC AND FIBTEM A5 ≥ 8 MM 4F-PCC 20 IU/KG (F II, VII, IX and X) GOAL: EXTEM CT ≤ 80 SEC NO INTERVENTION FIBTEM A5 ≥ 12 MM AND EXTEM A5 ≥ 40 MM AND EXTEM CT \\> 80 SEC NO FIBRINOGEN, CRYO, PLATELETS, 4-PCC, FFP; TRANSFUSE RBC IF Hb \\< 7 G/DL GOAL: Hb \\> 7.5 G/DL\n\nGroup B RATIO / STANDRAD LAB TEST-GUIDED ALGORITHM CRYOPRECIPITATE FIBRINOGEN (CLAUSS) \\< 250 MG/DL FIB 200-250 MG/DL → CRYOS, PACK OF 10 (25 MG/KG); FIB 100-200 MG/DL → CRYOS, PACK OF 20 (50 MG/KG); FIB \\< 100 MG/DL → CRYOS, PACK OF 30 (75 MG/KG) GOAL: FIB \\> 250 MG/DL PLATELETS PLATELET COUNT \\< 100/µL PLT \\< 100/µL → 1 PLATELET POOL OR APHERESIS; PLT \\> 50/µL → 2 PLATELET POOL OR APHERESIS GOAL: PLT COUNT \\> 100/µL FRESH FROZEN PLASMA TP AND/OR TTP PATHOLOGICAL INR, 2.0-4.0 → FFP 20 ML/KG GOAL: TP AND TTP NORMAL AND INR \\< 2.0 NO LAB RESULTS AVAILABLE TRANSFUSE RED BLOOD CELLS IF Hb \\< 7 G/DL; GIVE 1 UNIT FFP EVERY 2 UNITS OF RBC TRANSFUSED GOAL: Hb \\> 7.5 G/DL Statistical analysis Sample is calculated to known variance. The investigators calculated that 100 women will be needed to provide 80% power at the two-sided 5% level to detect a difference of total allogeneic units between groups. With a total of 100 patients 50 in each arm, with a first revision of results after recruiting 50 patients (25 in each arm). Analyses are intention-to-treat without imputation, with outcomes will be performed between groups using mixed-effects two level regression models. For binary outcomes, a logistic model will be used and results presented as adjusted odds ratios (ORs) alongside 95% confidence intervals (CIs). For continuous outcomes, a linear regression model will be performed and results presented as difference in adjusted means (arm A vs arm B) alongside 95% CIs. Count data will be analysed using Poisson multilevel or negative binomial models if over-dispersion is evident and presented as incident rate ratios (IRRs).\n\nObjectives\n\nPrimary Outcome Parameter:\n\nCompare between the two protocols:\n\nNumber of allogeneic blood products transfused intra-op, within 24h after screening and in-hospital (RBC, Platelets and FFP; separate and overall)\n\nSecondary Outcome Parameter:\n\nCompare between the two arms Number of packs of Cryo (pack of 5 \\~ 1 G Fibrinogen), Fibrinogen Concentrate (G), and PCC (500 UI) administered intra-op, within 24h after screening and in-hospital Incidence ≥ 5 U RBC transfused (first 24h after screening) Incidence ≥ 10 U RBC transfused (first 24h after screening) Incidence of RBC, Platelets, FFP, Cryo, Fibrinogen Concentrate, and PCC transfusion/administration (intra-op, first 24h and in-hospital) Total volume of blood products and coagulation factor concentrates transfused/administered (intra-op, first 24h and in-hospital) Infusion: Crystalloid (ML) and Colloids (Type; ML) intra-op and within 24h after screening Overall estimated blood loss (EBL, ML) Time to bleeding control (time from study entry to last hemostatic intervention/transfusion) Incidence of coagulopathy (detected by thromboelastometry or standard coagulation laboratory tests) Incidence of hysterectomy Incidence of re-surgery Incidence of TACO Incidence of TRALI Incidence of surgical site infection or sepsis Incidence of ICU admission Length of stay (LOS) at ICU and hospital In-hospital mortality First post-op Hb, Hct, Plt count, Fibrinogen (Clauss), PT, INR, PTT (recovery room or ICU) Last Hb, Hct, Plt count, Fibrinogen (Clauss), PT, INR, PTT before discharge from hospital Total acquisition costs of allogeneic blood products and coagulation factor concentrates HYPOTHESIS. The algorithm guided by ROTEM plus the use of hemostatic drugs, are more efficient for the reversion of coagulopathy due to obstetric hemorrhage, than the standard treatment group, decrases the risk of development known complications, decreases the need of blood transfusions, decreases morbidity and mortality associated to PPH, length of stay, admissions to the intensive care unit and days of mechanical ventilation. Without a significant increase in costs.\n\nRELEVANCE AND EXPECTATIONS To offer a safe alternative in the treatment of severe obstetric hemorrhage, which reduces the risk of transfusion associated complications,'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'all female patients with severe obstetric hemorrhage (more than 1000 ml of estimated blood loss)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with severe obstetric hemorrhage of any cause\n\nExclusion Criteria:\n\nobstetric hemorrhage patients derived from other hospitals Patients with less than 1000 ml of estimated blood loss those who do not want to participate in the study'}, 'identificationModule': {'nctId': 'NCT03784794', 'briefTitle': 'Patient Blood Management for Massive Obstetric Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Grupo Mexicano para el Estudio de la Medicina Intensiva'}, 'officialTitle': 'ROTEM Guided and Hemostatic Drugs Algorithms vs Standard Coagulation Test and Hemocomponent for Massive Obstetric Hemorrhage', 'orgStudyIdInfo': {'id': '099/21012018/MEDCRITICAHENM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thromboelastometry', 'description': 'Decision to treat will be guided with thromboelastometry results, for fribrinogen deficiency the investigators will treat with fibrinogen concentrate (human), for correction of factor deficiency Prothrombin Complex Concentrates, Platelets with the use of platelets and Red Blood Cells for correcting hemoglobin levels', 'interventionNames': ['Diagnostic Test: Thromboelastometry', 'Drug: Fibrinogen Concentrate Human', 'Drug: Prothrombin Complex Concentrates', 'Other: Platelets', 'Other: Red Blood Cells']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'STANDARD COAGULATION TEST ALGORITHM', 'description': 'Decision to treat will be guided by standard cogulation lab test (Thrombine time, Active Thromboplastine time, Clauss fibrinogen, platelets count etc) for fribrinogen deficiency the investigators will treat with cryoprecipitates, for correction of factor deficiency fresh frozen plasma, Platelets with the use of platelets and Red Blood Cells for correcting hemoglobin levels', 'interventionNames': ['Diagnostic Test: Standard Coagulation Test', 'Other: Platelets', 'Other: Red Blood Cells', 'Other: Fresh Frozen Plasma', 'Other: cryoprecipitates']}], 'interventions': [{'name': 'Thromboelastometry', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['ROTEM'], 'description': 'devices generate output by transducing changes in the viscoelastic strength of a small sample of clotting blood (300 µl) to which a constant rotational force is applied. These point of care devices allow visual assessment of blood coagulation from clot formation, through propagation, and stabilization, until clot dissolution. Computer analysis of the output allows sophisticated clot formation/dissolution kinetics and clot strength data to be generated', 'armGroupLabels': ['Thromboelastometry']}, {'name': 'Standard Coagulation Test', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['blood coagulation test'], 'description': 'coagulation tests, such as the prothrombin time (PT), activated partial thromboplastin time (aPTT), and thrombin time (TT), to assess blood clotting function in patients. Clauss Fibrinogen.', 'armGroupLabels': ['STANDARD COAGULATION TEST ALGORITHM']}, {'name': 'Fibrinogen Concentrate Human', 'type': 'DRUG', 'otherNames': ['Chlotafact'], 'description': 'To treat acquired fribinogen deficiency investigators will treat with the following doses FIBTEM A5 = 9-11 MM a 2 G FIBRINOGEN CONC. (25 MG/KG); FIBTEM A5 = 4-8 MM a 4 G FIBRINOGEN CONC. (50 MG/KG); FIBTEM A5 \\< 4 MM a 6 G FIBRINOGEN CONC. (75 MG/KG)', 'armGroupLabels': ['Thromboelastometry']}, {'name': 'Prothrombin Complex Concentrates', 'type': 'DRUG', 'otherNames': ['Confidex'], 'description': 'to treat acquired factor deficiency investigators will treat as follows PROTROMBIN COMPLEX CONCENTRATE EXTEM CT \\> 80 SEC AND FIBTEM A5 ≥ 8 MM 4F-PCC 20 IU/KG (F II, VII, IX and X) GOAL: EXTEM CT ≤ 80 SEC', 'armGroupLabels': ['Thromboelastometry']}, {'name': 'Platelets', 'type': 'OTHER', 'description': 'PLATELETS EXTEM A5 \\< 40 MM AND FIBTEM A5 ≥ 12 MM EXTEM A5 \\< 40 MM → 1 PLATELET POOL OR APHERESIS; EXTEM A5 \\< 30 MM → 2 PLATELET POOL OR APHERESIS GOAL: EXTEM A5: 40-50 MM or PLATELET COUNT \\< 100/µL PLT \\< 100/µL → 1 PLATELET POOL OR APHERESIS; PLT \\> 50/µL → 2 PLATELET POOL OR APHERESIS GOAL: PLT COUNT \\> 100/µL', 'armGroupLabels': ['STANDARD COAGULATION TEST ALGORITHM', 'Thromboelastometry']}, {'name': 'Red Blood Cells', 'type': 'OTHER', 'otherNames': ['RBC'], 'description': 'Transfuce Red Blood Cells if Hemoglobine levels \\< 7 G/DL;\n\n1 unit of FFP for every unit of RBC Transfused GOAL: Hb \\> 7.5 G/DL', 'armGroupLabels': ['STANDARD COAGULATION TEST ALGORITHM', 'Thromboelastometry']}, {'name': 'Fresh Frozen Plasma', 'type': 'OTHER', 'description': 'FRESH FROZEN PLASMA TP AND/OR TTP PATHOLOGICAL INR, 2.0-4.0 → FFP 20 ML/KG GOAL: TP AND TTP NORMAL AND INR \\< 2.0', 'armGroupLabels': ['STANDARD COAGULATION TEST ALGORITHM']}, {'name': 'cryoprecipitates', 'type': 'OTHER', 'description': 'FIBRINOGEN (CLAUSS) \\< 250 MG/DL FIB 200-250 MG/DL → CRYOS, PACK OF 10 (25 MG/KG); FIB 100-200 MG/DL → CRYOS, PACK OF 20 (50 MG/KG); FIB \\< 100 MG/DL → CRYOS, PACK OF 30 (75 MG/KG) GOAL: FIB \\> 250 MG/DL', 'armGroupLabels': ['STANDARD COAGULATION TEST ALGORITHM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76090', 'city': 'Querétaro City', 'state': 'Querétaro', 'country': 'Mexico', 'facility': 'Hospital de Especialidades Del Niño Y La Mujer', 'geoPoint': {'lat': 20.58806, 'lon': -100.38806}}], 'overallOfficials': [{'name': 'Angel Augusto Perez Calatayud, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head Obstetric ICU'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'after recruiting 50% of the participants and it will be available always', 'ipdSharing': 'YES', 'description': 'no plan for sharing data has been made', 'accessCriteria': 'open'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Angel Augusto Perez Calatayud', 'class': 'OTHER'}, 'collaborators': [{'name': 'Grupo Mexicano para el Estudio de la Medicina Intensiva', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head Intensive Care Unit Hospital de Especialidades del Niño y la Mujer Dr Felipe Nuñez Lara', 'investigatorFullName': 'Angel Augusto Perez Calatayud', 'investigatorAffiliation': 'Grupo Mexicano para el Estudio de la Medicina Intensiva'}}}}