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

Not Applicable

Terminated

• Conditions: Hemorrhage

• Registration Number: NCT03703323
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

Brief 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.

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 Timeline

• Study Start: 2018-10-08
• Study First Submitted: 2018-10-09
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-11
• Primary Completion: 2020-08-08
• Study Completion: 2020-08-21
• Status Verified: 2021-01
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mortality	day 28	28-day mortality rate

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHR Metz Thionville; 🇫🇷 Metz, France