Patient Blood Management for Massive Obstetric Hemorrhage

• Status: Completed
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Angel Augusto Perez Calatayud
• Collaborator: Grupo Mexicano para el Estudio de la Medicina Intensiva
• Treatments: Thrombin

Criteria

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