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

NCT ID: NCT03703323

Last Updated: 2021-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-08

Study Completion Date

2020-08-21

Brief Summary

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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

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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.

Conditions

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Hemorrhage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Rotative thromboelastometry analysis

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

Group Type EXPERIMENTAL

Rotative thromboelastometry analysis

Intervention Type OTHER

Obtaining blood sample (one tube of blood)

Interventions

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Rotative thromboelastometry analysis

Obtaining blood sample (one tube of blood)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHR Metz Thionville

Metz, , France

Site Status

Countries

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France

Other Identifiers

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2018-03-CHRMT

Identifier Type: -

Identifier Source: org_study_id