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Thromboelastometry-guided Treatment Protocol Versus Standard Care of Major Haemorrhage in Obstetric Patients (ROTEM-PPH)

Primary Purpose

Obstetric Labor Complications, Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Rotational Thromboelastometry (ROTEM)
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstetric Labor Complications focused on measuring Thromboelastometry, Obstetric Hemorrhage, Blood Component Transfusion

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Tampere University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rotational thromboelastometry (ROTEM)

Standard care

Arm Description

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.

Patients are treated according to clinical decision making and conventional coagulation tests, and in case of massive hemorrhage, "shock packs" are administered.

Outcomes

Primary Outcome Measures

Reduction in blood transfusions

Secondary Outcome Measures

Reduction of transfusion related side-effects
Number of thromboembolic events

Full Information

First Posted
May 29, 2015
Last Updated
January 27, 2020
Sponsor
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02461251
Brief Title
Thromboelastometry-guided Treatment Protocol Versus Standard Care of Major Haemorrhage in Obstetric Patients
Acronym
ROTEM-PPH
Official Title
Thromboelastometry-guided Treatment Protocol Versus Standard Care of Major Haemorrhage in Obstetric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampere University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Labor Complications, Hemorrhage
Keywords
Thromboelastometry, Obstetric Hemorrhage, Blood Component Transfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rotational thromboelastometry (ROTEM)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Patients are treated according to clinical decision making and conventional coagulation tests, and in case of massive hemorrhage, "shock packs" are administered.
Intervention Type
Device
Intervention Name(s)
Rotational Thromboelastometry (ROTEM)
Intervention Description
A Point-of-care blood coagulation test tool is used to guide the treatment of major obstetric bleeding.
Primary Outcome Measure Information:
Title
Reduction in blood transfusions
Time Frame
24 h
Secondary Outcome Measure Information:
Title
Reduction of transfusion related side-effects
Time Frame
30 days
Title
Number of thromboembolic events
Time Frame
30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Kuitunen, MD, PhD
Organizational Affiliation
Tampere University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Samuli Jokinen, MD
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33560
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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