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NCT03703323 Clinical Trial

Comparison of Mortality Impact of Coagulation Rotative Thromboelastometry Analysis Versus Standard Analysis

Hemorrhage Clinical Trial

— HD-ROTEM  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03703323
Other study ID # 2018-03-CHRMT
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 8, 2018
Est. completion date August 21, 2020

Study information
Verified date January 2021
Source Centre Hospitalier Régional Metz-Thionville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 13
Est. completion date August 21, 2020
Est. primary completion date August 8, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Rotative thromboelastometry analysis
Obtaining blood sample (one tube of blood)

Locations
Country Name City State
France CHR Metz Thionville Metz

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality 28-day mortality rate day 28
Secondary Fresh-frozen plasma Number of fresh-frozen plasma used within the first 48 hours of the care day 2
Secondary Length of stay Lenght of stay in reanimation unit day 28
Secondary Recurrent bleeding recurrent bleeding within the first 48 hours Day 2
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