Comparison of Mortality Impact of Coagulation Rotative Thromboelastometry Analysis Versus Standard Analysis (HD-ROTEM)

Centre Hospitalier Régional Metz-Thionville

Status: Terminated

Conditions: Hemorrhage

Treatments: Other: Rotative thromboelastometry analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT03703323

2018-03-CHRMT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Rotative thromboelastometry analysis

Experimental group

Description:

Evaluation of diagnostic properties of coagulation by rotative thromboelastometry in patient with digestive hemorrhage in predictive value of mortality.

Treatment:

Other: Rotative thromboelastometry analysis