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NCT Number: NCT02461251

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

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.

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Key information

Conditions

Obstetric Labor Complications Female Urogenital Diseases and Pregnancy Complications Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University Hospital

Tampere, 33560, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rotational Thromboelastometry (ROTEM)

Device

A Point-of-care blood coagulation test tool is used to guide the treatment of major obstetric bleeding.

Primary outcomes

  1. Reduction in blood transfusions

    Time frame: 24 h

Secondary outcomes

  1. Reduction of transfusion related side-effects

    Time frame: 30 days

  2. Number of thromboembolic events

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Acronym: ROTEM-PPH

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 3, 2015
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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