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

Hemorrhage Clinical Trial

— ROTEM-PPH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461251
• Other study ID #: ETL R15054
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 2020

Study information

• Verified date: January 2020
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hemorrhage
• Obstetric Labor Complications

Intervention

Device:
• Rotational Thromboelastometry (ROTEM)
A Point-of-care blood coagulation test tool is used to guide the treatment of major obstetric bleeding.

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in blood transfusions		24 h
Secondary	Reduction of transfusion related side-effects		30 days
Secondary	Number of thromboembolic events		30 days