Clinical trial NCT02461251: Thromboelastometry-guided Treatment Protocol Versus Standard Care of Major Haemorrhage in Obstetric Patients
Official title: Thromboelastometry-guided Treatment Protocol Versus Standard Care of Major Haemorrhage in Obstetric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstetric Labor Complications
Hemorrhage
Keywords: Thromboelastometry
Obstetric Hemorrhage
Blood Component Transfusion
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Reduction in blood transfusions
timeFrame: 24 h
Secondary outcomes:
measure: Reduction of transfusion related side-effects
timeFrame: 30 days
measure: Number of thromboembolic events
timeFrame: 30 days
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Anne Kuitunen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Tampere University Hospital
name: Samuli Jokinen, MD
role: PRINCIPAL_INVESTIGATOR
References: