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Patient Blood Management for Massive Obstetric Hemorrhage

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ClinicalTrials.gov Identifier: NCT03784794
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : December 24, 2018
Sponsor:
Collaborator:
Grupo Mexicano para el Estudio de la Medicina Intensiva
Information provided by (Responsible Party):
Angel Augusto Perez Calatayud, Grupo Mexicano para el Estudio de la Medicina Intensiva

Brief 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.


Condition or disease Intervention/treatment Phase
Post Partum Hemorrhage Fibrinogenolysis; Hemorrhage Fibrinogen; Deficiency, Acquired Massive Hemorrhage Transfusion Related Complication Diagnostic Test: Thromboelastometry Diagnostic Test: Standard Coagulation Test Drug: Fibrinogen Concentrate Human Drug: Prothrombin Complex Concentrates Other: Platelets Other: Red Blood Cells Other: Fresh Frozen Plasma Other: cryoprecipitates Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group A Fibrinogen Concentrate, Protrombin Complex Concentrate, trhromboelastometry guided Group B Cryoprecipitates, fresh frozen plasma, standard coagulation lab test
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ROTEM Guided and Hemostatic Drugs Algorithms vs Standard Coagulation Test and Hemocomponent for Massive Obstetric Hemorrhage
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Thromboelastometry
Decision to treat will be guided with thromboelastometry results, for fribrinogen deficiency the investigators will treat with fibrinogen concentrate (human), for correction of factor deficiency Prothrombin Complex Concentrates, Platelets with the use of platelets and Red Blood Cells for correcting hemoglobin levels
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
Other Name: ROTEM

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)
Other Name: Chlotafact

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 Name: Confidex

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 Name: RBC

Active Comparator: STANDARD COAGULATION TEST ALGORITHM
Decision to treat will be guided by standard cogulation lab test (Thrombine time, Active Thromboplastine time, Clauss fibrinogen, platelets count etc) for fribrinogen deficiency the investigators will treat with cryoprecipitates, for correction of factor deficiency fresh frozen plasma, Platelets with the use of platelets and Red Blood Cells for correcting hemoglobin levels
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.
Other Name: blood coagulation test

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 Name: RBC

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




Primary Outcome Measures :
  1. Number of Blood products transfused [ Time Frame: 24 hrs ]
    Number of allogeneic blood products transfused intra-op, within 24h after screening and in-hospital (RBC, Platelets and FFP; separate and overall)


Secondary Outcome Measures :
  1. Number of hemocomponents or fibrinogen concentrates needed to treat hypofibrinogenemia [ Time Frame: day 0 to day 15 ]
    Number of packs of Cryo (pack of 5 ~ 1 G Fibrinogen), Fibrinogen Concentrate (G), and PCC (500 UI) administered intra-operating

  2. Incidence of Red Blood Cells transfusion (RBC) [ Time Frame: day 0 to day 15 ]
    Incidence ≥ 5 U RBC transfused

  3. Incidence of Massive Red Blood Cells transfusion (RBC) [ Time Frame: day 0 to day 15 ]
    Incidence ≥ 10 U RBC transfused (first 24h after screening)

  4. estimated blood loss [ Time Frame: day 0 to day 15 ]
    Overall estimated blood loss (EBL, ML)

  5. Time to bleeding control [ Time Frame: 24 hrs ]
    time from study entry to last hemostatic intervention/transfusion

  6. Incidence of coagulopathy [ Time Frame: day 0 to day 15 ]
    detected by thromboelastometry or standard coagulation laboratory tests

  7. Incidence of hysterectomy [ Time Frame: day 0 to day 15 ]
    number of obstetric hysterectomy for bleeding control

  8. Incidence of re-surgery [ Time Frame: day 0 to day 15 ]
    number of procedures necessary for bleeding control

  9. Incidence of Transfused associated circulatory overload [ Time Frame: day 0 to day 15 ]
    number of patients with transfused associated circulatory overload

  10. Incidence of surgical site infection or sepsis [ Time Frame: day 0 to day 15 ]
    number of patients that developed health care related infections or sepsis

  11. Incidence of ICU admission [ Time Frame: day 0 to day 15 ]
    number of patients that require admission to the ICU for complications related to hipovolemic shock

  12. In-hospital mortality [ Time Frame: day 0 to day 15 ]
    number of deaths



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   all female patients with severe obstetric hemorrhage (more than 1000 ml of estimated blood loss)
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784794


Contacts
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Contact: Angel Augusto Perez-Calatayud, M.D. 525542389377 gmemiinv@gmail.com
Contact: Nelson Bautista, M.D. M.S. 524422919200 luisnelsonb@yahoo.com.mx

Locations
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Mexico
Hospital de Especialidades Del Niño Y La Mujer Recruiting
Querétaro City, Queretaro, Mexico, 76090
Contact: Nelson Bautista, M.D.    524422919200 ext 2213    luisnelsonb@yahoo.com.mx   
Principal Investigator: Angel Augusto Perez Calatayud, MD         
Sub-Investigator: Klaus Gorlingër, PhD         
Sub-Investigator: Luisa Fernanda Giraldo, MD         
Sub-Investigator: Eduardo Daniel Anica Malagon, MD         
Sub-Investigator: Emilio Arch Tirado, PhD         
Sponsors and Collaborators
Angel Augusto Perez Calatayud
Grupo Mexicano para el Estudio de la Medicina Intensiva
Investigators
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Principal Investigator: Angel Augusto Perez Calatayud, M.D. Head Obstetric ICU

Publications of Results:
Other Publications:

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Responsible Party: Angel Augusto Perez Calatayud, Head Intensive Care Unit Hospital de Especialidades del Niño y la Mujer Dr Felipe Nuñez Lara, Grupo Mexicano para el Estudio de la Medicina Intensiva
ClinicalTrials.gov Identifier: NCT03784794     History of Changes
Other Study ID Numbers: 099/21012018/MEDCRITICAHENM
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Angel Augusto Perez Calatayud, Grupo Mexicano para el Estudio de la Medicina Intensiva:
Post Partum Hemorrhage
Massive tranfusion
Thromboelastometry

Additional relevant MeSH terms:
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Hemorrhage
Postpartum Hemorrhage
Disseminated Intravascular Coagulation
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhagic Disorders
Thrombophilia
Thrombin
Hemostatics
Coagulants