Nutritional Status of Patients Victims of Haemorragic Accidents With Antivitamins K

Denutrition Clinical Trial

Official title:

Nutritional Status of Patients Victims of Haemorragic Accidents With Antivitamins K

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01742871
• Other study ID #: CHU-0131
• Secondary ID: 2012-A00331-42
• Status: Recruiting
• Phase: N/A
• First received: December 4, 2012
• Last updated: December 4, 2012
• Start date: August 2012
• Est. completion date: January 2014

Study information

• Verified date: December 2012
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Denutrition
• Hemorrhagic Accident
• Iatrogeny

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Denutrition diagnosis		at day 1	Yes
Secondary	Zinc blood level		at day 1	Yes
Secondary	Cupper blood level		at day 1	Yes
Secondary	vitamin C blood level		at day 1	Yes
Secondary	vitamin B1 blood level		at day 1	Yes
Secondary	PINI (pronostic inflammatory and nutritional index)		at day 1	Yes
Secondary	NRI (nutritional risk index)		at day 1	Yes
Secondary	The outpatient bleeding risk index		at day 1	Yes
Secondary	Stiffness index		at day 1	Yes
Secondary	Rumpel-Leede test		at day 1	Yes