Nutritional Status of Patients Victims of Haemorragic Accidents With Antivitamins K

• Conditions: Hemorrhagic Accident; Iatrogeny; Denutrition

• Registration Number: NCT01742871
• Lead Sponsor: University Hospital, Clermont-Ferrand

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

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 Timeline

• Study Start: 2012-08
• Status Verified: 2012-12
• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-04
• Last Update Submitted: 2012-12-04
• Study First Posted: 2012-12-06
• Last Update Posted: 2012-12-06
• Primary Completion: 2014-01
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Denutrition diagnosis	at day 1

Secondary Outcome Measures

Name	Time	Method
Zinc blood level	at day 1
Cupper blood level	at day 1
vitamin C blood level	at day 1
vitamin B1 blood level	at day 1
PINI (pronostic inflammatory and nutritional index)	at day 1
NRI (nutritional risk index)	at day 1
The outpatient bleeding risk index	at day 1
Stiffness index	at day 1
Rumpel-Leede test	at day 1

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France