Comparison of Mortality Impact of Coagulation Rotative Thromboelastometry Analysis Versus Standard Analysis (HD-ROTEM)

November 29, 2021 updated by: Centre Hospitalier Régional Metz-Thionville

Comparison of Mortality Impact of Coagulation Rotative Thromboelastometry Analysis Versus Standard Analysis (Prothrombin Ratio) for Patients With Digestive Hemorrage

Digestive hemorrhage is a common cause of acute hemorrhage in France, and its mortality remains high despite improvement of endoscopy technique and therapeutics. Hemostasis disorders are an important issue in the patient care both in severity diagnostic and therapeutic plan.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Standard technique of coagulation analysis (prothrombin ratio, activated partial thromboplastin time, fibrinogen and platelet count) do not provide to guide practitioner in reanimation of hemostatic patients in particular when coagulation defect preexisting to the digestive hemorrhage.

In this respect, the main objective of this study is to evaluate the interest of rotative thromboelastometry in the care of patient with digestive hemorrhage and its mortality impact.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Metz, France, 57085
        • CHR Metz Thionville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hospitalized patient in reanimation unit or continuous monitoring for digestive hemorrhage before or immediately after digestive endoscopy
  • Digestive hemorrhage diagnostic: melena and/or rectal bleeding and/or hematemesis
  • Affiliation to the social security
  • Have signed an informed consent

Exclusion Criteria:

  • Pregnant or nursing woman
  • Without digestive fibroscopy
  • With an anticoagulant treatment
  • With a congenital coagulopathy
  • Decision of therapeutic limitation or moribund patient
  • With a digestive hemorrhage after an hospitalisation in reanimation unit for an other reason
  • Participation in an other study in previous 30 days
  • Under trusteeship, guardianship or judicial safeguards

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rotative thromboelastometry analysis
Evaluation of diagnostic properties of coagulation by rotative thromboelastometry in patient with digestive hemorrhage in predictive value of mortality.
Other: Rotative thromboelastometry analysis
Obtaining blood sample (one tube of blood)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: day 28
28-day mortality rate
day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fresh-frozen plasma
Time Frame: day 2
Number of fresh-frozen plasma used within the first 48 hours of the care
day 2
Length of stay
Time Frame: day 28
Lenght of stay in reanimation unit
day 28
Recurrent bleeding
Time Frame: Day 2
recurrent bleeding within the first 48 hours
Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional Metz-Thionville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 8, 2018

Primary Completion (ACTUAL)

August 8, 2020

Study Completion (ACTUAL)

August 21, 2020

Study Registration Dates

First Submitted

October 9, 2018

First Submitted That Met QC Criteria

October 9, 2018

First Posted (ACTUAL)

October 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 29, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-03-CHRMT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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