Thromboelastometry-guided Treatment Protocol Versus Standard Care of Major Haemorrhage in Obstetric Patients
ROTEM-PPH
1 other identifier
interventional
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2015
CompletedFirst Posted
Study publicly available on registry
June 3, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedJanuary 29, 2020
January 1, 2020
4 years
May 29, 2015
January 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in blood transfusions
24 h
Secondary Outcomes (2)
Reduction of transfusion related side-effects
30 days
Number of thromboembolic events
30 days
Study Arms (2)
Rotational thromboelastometry (ROTEM)
EXPERIMENTALRotational 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.
Standard care
NO INTERVENTIONPatients are treated according to clinical decision making and conventional coagulation tests, and in case of massive hemorrhage, "shock packs" are administered.
Interventions
A Point-of-care blood coagulation test tool is used to guide the treatment of major obstetric bleeding.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Known hemophilia or von Willebrand's disease
- Unacceptance of allogeneic blood products(Jehovah's witnesses)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tampere University Hospital
Tampere, 33560, Finland
Related Publications (1)
Jokinen S, Kuitunen A, Uotila J, Yli-Hankala A. Thromboelastometry-guided treatment algorithm in postpartum haemorrhage: a randomised, controlled pilot trial. Br J Anaesth. 2023 Feb;130(2):165-174. doi: 10.1016/j.bja.2022.10.031. Epub 2022 Dec 7.
PMID: 36496259DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anne Kuitunen, MD, PhD
Tampere University Hospital
- PRINCIPAL INVESTIGATOR
Samuli Jokinen, MD
Tampere University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2015
First Posted
June 3, 2015
Study Start
January 1, 2016
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
January 29, 2020
Record last verified: 2020-01