Post Partum Hemorrhage Clinical Trial
Official title:
ROTEM Guided and Hemostatic Drugs Algorithms vs Standard Coagulation Test and Hemocomponent for Massive Obstetric Hemorrhage
Verified date | June 2021 |
Source | Grupo Mexicano para el Estudio de la Medicina Intensiva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. Primary Outcome Parameter: Compare between the two protocols: Number of allogeneic blood products transfused intra-op, within 24h after screening and in-hospital (RBC, Platelets and FFP; separate and overall) Secondary Outcome Parameter: Analysis 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.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 30, 2020 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: Patients with severe obstetric hemorrhage of any cause Exclusion Criteria: obstetric 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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital de Especialidades Del Niño Y La Mujer | Querétaro City | Queretaro |
Lead Sponsor | Collaborator |
---|---|
Angel Augusto Perez Calatayud | Grupo Mexicano para el Estudio de la Medicina Intensiva |
Mexico,
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Blood products transfused | Number of allogeneic blood products transfused intra-op, within 24h after screening and in-hospital (RBC, Platelets and FFP; separate and overall) | 24 hrs | |
Secondary | Number of hemocomponents or fibrinogen concentrates needed to treat hypofibrinogenemia | Number of packs of Cryo (pack of 5 ~ 1 G Fibrinogen), Fibrinogen Concentrate (G), and PCC (500 UI) administered intra-operating | day 0 to day 15 | |
Secondary | Incidence of Red Blood Cells transfusion (RBC) | Incidence = 5 U RBC transfused | day 0 to day 15 | |
Secondary | Incidence of Massive Red Blood Cells transfusion (RBC) | Incidence = 10 U RBC transfused (first 24h after screening) | day 0 to day 15 | |
Secondary | estimated blood loss | Overall estimated blood loss (EBL, ML) | day 0 to day 15 | |
Secondary | Time to bleeding control | time from study entry to last hemostatic intervention/transfusion | 24 hrs | |
Secondary | Incidence of coagulopathy | detected by thromboelastometry or standard coagulation laboratory tests | day 0 to day 15 | |
Secondary | Incidence of hysterectomy | number of obstetric hysterectomy for bleeding control | day 0 to day 15 | |
Secondary | Incidence of re-surgery | number of procedures necessary for bleeding control | day 0 to day 15 | |
Secondary | Incidence of Transfused associated circulatory overload | number of patients with transfused associated circulatory overload | day 0 to day 15 | |
Secondary | Incidence of surgical site infection or sepsis | number of patients that developed health care related infections or sepsis | day 0 to day 15 | |
Secondary | Incidence of ICU admission | number of patients that require admission to the ICU for complications related to hipovolemic shock | day 0 to day 15 | |
Secondary | In-hospital mortality | number of deaths | day 0 to day 15 |
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