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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03703323

Acronym

HD-ROTEM

Enrollment

Registered

2018-10-11

Start date

2018-10-08

Completion date

2020-08-21

Last updated

2021-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhage

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.

Interventions

OTHERRotative thromboelastometry analysis

Obtaining blood sample (one tube of blood)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Mortality	day 28	28-day mortality rate

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026