- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01742871
Nutritional Status of Patients Victims of Haemorragic Accidents With Antivitamins K
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Clermont-Ferrand, France, 63003
- Recruiting
- CHU Clermont-Ferrand
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Principal Investigator:
- Jeannot SCHMIDT
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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controls
Patient under anti-vitamin K with no haemorrhagic manifestations admitted for another reason to Emergency Adults
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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 ®).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Denutrition diagnosis
Time Frame: at day 1
|
at day 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Zinc blood level
Time Frame: at day 1
|
at day 1
|
Cupper blood level
Time Frame: at day 1
|
at day 1
|
vitamin C blood level
Time Frame: at day 1
|
at day 1
|
vitamin B1 blood level
Time Frame: at day 1
|
at day 1
|
PINI (pronostic inflammatory and nutritional index)
Time Frame: at day 1
|
at day 1
|
NRI (nutritional risk index)
Time Frame: at day 1
|
at day 1
|
The outpatient bleeding risk index
Time Frame: at day 1
|
at day 1
|
Stiffness index
Time Frame: at day 1
|
at day 1
|
Rumpel-Leede test
Time Frame: at day 1
|
at day 1
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CHU-0131
- 2012-A00331-42
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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