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Trial record 72 of 6670 for:    Recruiting, Not yet recruiting, Available Studies | Digestion

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03703323
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : October 15, 2018
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville

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.

Condition or disease Intervention/treatment Phase
Hemorrhage Other: Rotative thromboelastometry analysis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Mortality Impact of Coagulation Rotative Thromboelastometry Analysis Versus Standard Analysis (Prothrombin Ratio) for Patients With Digestive Hemorrage
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : August 8, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Rotative thromboelastometry analysis
Evaluation of diagnostic properties of coagulation by rotative thromboelastometry in patient with digestive hemorrhage in predictive value of mortality.
Other: Rotative thromboelastometry analysis
Obtaining blood sample (one tube of blood)

Primary Outcome Measures :
  1. Mortality [ Time Frame: day 28 ]
    28-day mortality rate

Secondary Outcome Measures :
  1. Fresh-frozen plasma [ Time Frame: day 2 ]
    Number of fresh-frozen plasma used within the first 48 hours of the care

  2. Length of stay [ Time Frame: day 28 ]
    Lenght of stay in reanimation unit

  3. Recurrent bleeding [ Time Frame: Day 2 ]
    recurrent bleeding within the first 48 hours

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03703323

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Contact: Serge Le Tacon, PhD 387179882
Contact: Sandra Marchionni 387557750 ext 0033

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CHR Metz Thionville Recruiting
Metz, France, 57085
Contact: Nadia OUAMARA    387557750 ext 0033   
Sponsors and Collaborators
Centre Hospitalier Régional Metz-Thionville

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Responsible Party: Centre Hospitalier Régional Metz-Thionville Identifier: NCT03703323     History of Changes
Other Study ID Numbers: 2018-03-CHRMT
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pathologic Processes