Thromboelastometry-guided Treatment Protocol Versus Standard Care of Major Haemorrhage in Obstetric Patients
NCT02461251 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2020-01-29
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.
Conditions
- Obstetric Labor Complications
- Hemorrhage
Interventions
- DEVICE
-
Rotational Thromboelastometry (ROTEM)
A Point-of-care blood coagulation test tool is used to guide the treatment of major obstetric bleeding.
Sponsors & Collaborators
-
Tampere University Hospital
lead OTHER
Principal Investigators
-
Anne Kuitunen, MD, PhD · Tampere University Hospital
-
Samuli Jokinen, MD · Tampere University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-31
- Primary Completion
- 2020-01-31
- Completion
- 2020-01-31
Countries
- Finland
Study Locations
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