Patient Blood Management for Massive Obstetric Hemorrhage
Status:
Completed
Trial end date:
2020-12-30
Target enrollment:
Participant gender:
Summary
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.
Phase:
N/A
Details
Lead Sponsor:
Angel Augusto Perez Calatayud
Collaborator:
Grupo Mexicano para el Estudio de la Medicina Intensiva