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
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hemorrhage

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