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Nutritional Status of Patients Victims of Haemorragic Accidents With Antivitamins K

Sponsor
University Hospital, Clermont-Ferrand (Other)
Overall Status
Unknown status
CT.gov ID
NCT01742871
Collaborator
(none)
300
Enrollment
1
Location
17
Duration (Months)
17.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Bleeding under vitamin K antagonists are a major iatrogenic causes of hospitalization, subject to a fatal outcome in more than one third of cases, mortality is particularly high in cases of serious bleeding, including intracerebral hemorrhage. If the INR measured in these patients are often away from the higher value of the target range, a significant proportion of bleeding were observed for INR between 2 and 3. The study captures the components of the nutritional status of patients on oral anticoagulants, including any micronutrient deficiencies, to determine whether nutritional status is an independent risk factor for bleeding

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Be included in this study patients under anti-vitamin K supported or followed the emergency department Adults.

    The inclusion visit will be conducted in the emergency department Adults Clermont-Ferrand by an emergency physician or investigator or co-investigator. The protocol will be explained to patients in detail, the information document and consent will be issued for playback, then they will be asked to sign the consent form and participation agreement.

    Case-control study: patients under oral anticoagulant with severe hemorrhagic accident compared with patients without hemorrhagic accident. Cases will be matched to controls based on age, sex, and the value of the INR.

    Patients will be divided into two groups:

    • Group 1: cases Patient under anti-vitamin K with a serious bleeding event that required treatment in the emergency Adults. Is considered serious accident requiring the use of a reversion by PPSB (Kaskadil ®).

    • Group 2: contols Patient under anti-vitamin K with no haemorrhagic manifestations admitted for another reason to Emergency Adults

    Each case will be paired with two controls

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Nutritional Status of Patients Victims of Haemorragic Accidents With Antivitamins K
    Study Start Date :
    Aug 1, 2012
    Anticipated Primary Completion Date :
    Jan 1, 2014
    Anticipated Study Completion Date :
    Jan 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    controls

    Patient under anti-vitamin K with no haemorrhagic manifestations admitted for another reason to Emergency Adults
    kaskadil

    Patient under anti-vitamin K with a serious bleeding event that required treatment in the emergency Adults. Is considered serious accident requiring the use of a reversion by PPSB (Kaskadil ®).

    Outcome Measures

    Primary Outcome Measures

    1. Denutrition diagnosis [at day 1]

    Secondary Outcome Measures

    1. Zinc blood level [at day 1]

    2. Cupper blood level [at day 1]

    3. vitamin C blood level [at day 1]

    4. vitamin B1 blood level [at day 1]

    5. PINI (pronostic inflammatory and nutritional index) [at day 1]

    6. NRI (nutritional risk index) [at day 1]

    7. The outpatient bleeding risk index [at day 1]

    8. Stiffness index [at day 1]

    9. Rumpel-Leede test [at day 1]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients, male or female, aged over 18, under oral anticoagulant therapy with antivitamins K.

    • INR greater than 1.5, in the therapeutic range or overdose

    • Patient have read, understood and signed the consent form or inclusion emergency consent of the person with confidence

    • Case-control study: patients under oral anticoagulant with severe hemorrhagic accident compared with patients without hemorrhagic accident. Cases will be matched to controls based on age, sex, and the value of INR :

    Case:

    Patients victims of serious hemorrhagic accident on VKAs, supported emergency Adults.

    Will be considered severe hemorrhagic stroke, accidents requiring the use of a reversion by PPSB (Kaskadil ®)

    Control :

    Patients on VKAs supported the Emergency Adults for a reason other than bleeding.

    Exclusion Criteria:

    • underage patients

    • Patients who have not read or understood nor signed the consent form or refusal of the reference person.

    • pregnant women

    • Patients with a pacemaker and / or implantable defibrillator

    • Patients with mechanical valve

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Clermont-Ferrand Clermont-Ferrand France 63003

    Sponsors and Collaborators

    • University Hospital, Clermont-Ferrand

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Clermont-Ferrand
    ClinicalTrials.gov Identifier:
    NCT01742871
    Other Study ID Numbers:
    • CHU-0131
    • 2012-A00331-42
    First Posted:
    Dec 6, 2012
    Last Update Posted:
    Dec 6, 2012
    Last Verified:
    Dec 1, 2012
    Keywords provided by University Hospital, Clermont-Ferrand
    Antivitamin K
    Bleeding
    Haemorrhage
    Nutritional status
    impedancemetry

    Study Results

    No Results Posted as of Dec 6, 2012