Patient Blood Management for Massive Obstetric Hemorrhage

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

November 1, 2018

Primary Completion Date

November 30, 2020

Study Completion Date

December 30, 2020

Conditions
Post Partum HemorrhageFibrinogenolysis; HemorrhageFibrinogen; Deficiency, AcquiredMassive HemorrhageTransfusion Related Complication
Interventions
DIAGNOSTIC_TEST

Thromboelastometry

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

DIAGNOSTIC_TEST

Standard Coagulation Test

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.

DRUG

Fibrinogen Concentrate Human

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)

DRUG

Prothrombin Complex Concentrates

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

OTHER

Platelets

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

OTHER

Red Blood Cells

"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"

OTHER

Fresh Frozen Plasma

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

OTHER

cryoprecipitates

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

Trial Locations (1)

76090

Hospital de Especialidades Del Niño Y La Mujer, Querétaro City

All Listed Sponsors
collaborator

Grupo Mexicano para el Estudio de la Medicina Intensiva

OTHER

lead

Angel Augusto Perez Calatayud

OTHER

NCT03784794 - Patient Blood Management for Massive Obstetric Hemorrhage | Biotech Hunter | Biotech Hunter