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

No results posted yet for this study

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

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02461251 on ClinicalTrials.gov