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

Study Overview
=================
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.

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

Conditions
-----------------
Hemorrhage

Intervention / Treatment
-----------------
* Other: Rotative thromboelastometry analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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