Thromboelastometry-guided Treatment Protocol Versus Standard Care of Major Haemorrhage in Obstetric Patients

Study Overview
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Brief Summary
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This is a prospective, randomized and controlled study to find out if a rotational thromboelastometry(ROTEM) guided treatment protocol reduces the need for blood transfusions in major obstetric haemorrhage compared to standard care of clinical decision making, conventional coagulation tests and massive transfusion protocol. Secondary aim is to find out if ROTEM can predict the incidence of thromboembolic events in this patient group.

Detailed Description
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A comparison of two different treatment protocols is made in patients suffering major obstetric haemorrhage: those who after a normal delivery are bleeding more than 1000 ml and are in need of surgical intervention to control the bleeding and those in cesarean section with ongoing bleeding of more than 1000 ml. Patients are randomized in to two groups: the control group(n=30) will be treated according to a protocol based on clinical decision making, standard coagulation tests and massive transfusion packages of blood products(1:1:1), if needed. This is referred as 'Standard care' in this hospital. The intervention group(n=30) will be treated according to a rotational thromboelastometry guided protocol, and massive transfusion packages, if needed. The study is powered to detect a reduction of one unit in red blood cell transfusion. Blood product, fibrinogen concentrate, prothrombin complex concentrate usage and total amount of blood loss will be compared, and the number of transfusion related side effects and thromboembolic events 30 days after the bleeding will be recorded.

Official Title
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Thromboelastometry-guided Treatment Protocol Versus Standard Care of Major Haemorrhage in Obstetric Patients

Conditions
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Obstetric Labor Complications, Hemorrhage

Intervention / Treatment
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* Device: Rotational Thromboelastometry (ROTEM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 Severe post-partum haemorrhage ie. active bleeding of more than 1000ml within 24 hours after vaginal delivery or cesarean section Informed consent (after randomization) Exclusion Criteria: Known hemophilia or von Willebrand's disease Unacceptance of allogeneic blood products(Jehovah's witnesses)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rotational thromboelastometry (ROTEM)<br>Rotational thromboelastometry results are used to guide the treatment of major obstetric hemorrhage, eg. administration of prothrombin complex concentrate, fresh-frozen plasma, fibrinogen concentrate or platelets. In case of massive hemorrhage, shock packs of blood products in 1:1:1 ratio are administered. | Device: Rotational Thromboelastometry (ROTEM)<br>* A Point-of-care blood coagulation test tool is used to guide the treatment of major obstetric bleeding.<br>|
| No Intervention: Standard care<br>Patients are treated according to clinical decision making and conventional coagulation tests, and in case of massive hemorrhage, shock packs are administered. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in blood transfusions |  | 24 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of transfusion related side-effects |  | 30 days | 
| Number of thromboembolic events |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thromboelastometry, Obstetric Hemorrhage, Blood Component Transfusion