At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ROTEM Guided and Hemostatic Drugs Algorithms vs Standard Coagulation Test and Hemocomponent for Massive Obstetric Hemorrhage
In Brief
A clinical study evaluating Thromboelastometry, Standard Coagulation Test, and 6 other interventions for Post Partum Hemorrhage and 4 related conditions. Completed, enrolled 100 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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
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.
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)
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
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
Transfuce Red Blood Cells if Hemoglobine levels \< 7 G/DL; 1 unit of FFP for every unit of RBC Transfused GOAL: Hb \> 7.5 G/DL
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
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