Back to resultsComparison of Mortality Impact of Coagulation Rotative Thromboelastometry Analysis Versus Standard Analysis (HD-ROTEM)
Primary Purpose
Hemorrhage
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rotative thromboelastometry analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Hemorrhage
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
Sites / Locations
- CHR Metz Thionville
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rotative thromboelastometry analysis
Arm Description
Evaluation of diagnostic properties of coagulation by rotative thromboelastometry in patient with digestive hemorrhage in predictive value of mortality.
Outcomes
Primary Outcome Measures
Mortality
28-day mortality rate
Secondary Outcome Measures
Fresh-frozen plasma
Number of fresh-frozen plasma used within the first 48 hours of the care
Length of stay
Lenght of stay in reanimation unit
Recurrent bleeding
recurrent bleeding within the first 48 hours
Full Information
NCT ID
NCT03703323
First Posted
October 9, 2018
Last Updated
November 29, 2021
Sponsor
Centre Hospitalier Régional Metz-Thionville
1. Study Identification
Unique Protocol Identification Number
NCT03703323
Brief Title
Comparison of Mortality Impact of Coagulation Rotative Thromboelastometry Analysis Versus Standard Analysis
Acronym
HD-ROTEM
Official Title
Comparison of Mortality Impact of Coagulation Rotative Thromboelastometry Analysis Versus Standard Analysis (Prothrombin Ratio) for Patients With Digestive Hemorrage
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
pandemic situation
Study Start Date
October 8, 2018 (Actual)
Primary Completion Date
August 8, 2020 (Actual)
Study Completion Date
August 21, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional Metz-Thionville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rotative thromboelastometry analysis
Arm Type
Experimental
Arm Description
Evaluation of diagnostic properties of coagulation by rotative thromboelastometry in patient with digestive hemorrhage in predictive value of mortality.
Intervention Type
Other
Intervention Name(s)
Rotative thromboelastometry analysis
Intervention Description
Obtaining blood sample (one tube of blood)
Primary Outcome Measure Information:
Title
Mortality
Description
28-day mortality rate
Time Frame
day 28
Secondary Outcome Measure Information:
Title
Fresh-frozen plasma
Description
Number of fresh-frozen plasma used within the first 48 hours of the care
Time Frame
day 2
Title
Length of stay
Description
Lenght of stay in reanimation unit
Time Frame
day 28
Title
Recurrent bleeding
Description
recurrent bleeding within the first 48 hours
Time Frame
Day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHR Metz Thionville
City
Metz
ZIP/Postal Code
57085
Country
France
12. IPD Sharing Statement
Learn more about this trial
Comparison of Mortality Impact of Coagulation Rotative Thromboelastometry Analysis Versus Standard Analysis
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