Nutritional Status of Patients Victims of Haemorragic Accidents With Antivitamins K

NCT ID: NCT01742871

Last Updated: 2012-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-01-31

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

Conditions

Hemorrhagic Accident; Iatrogeny; Denutrition

Keywords

Antivitamin K; Bleeding; Haemorrhage; Nutritional status; impedancemetry

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

controls

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

No interventions assigned to this group

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 ®).

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Patrick LACARIN

Role: CONTACT

Phone: 04 73 75 11 95

Email: placarin@chu-clermontferrand.fr

Facility Contacts

Patrick LACARIN

Role: primary

References

Moustafa F, Dopeux L, Mulliez A, Boirie Y, Morand C, Gentes E, Farigon N, Richard D, Lebreton A, Teissandier D, Dutheil F, Schmidt J. Severe undernutrition increases bleeding risk on vitamin-K antagonists. Clin Nutr. 2021 Apr;40(4):2237-2243. doi: 10.1016/j.clnu.2020.10.002. Epub 2020 Oct 9.

Reference Type: DERIVED

PMID: 33077273 (View on PubMed)

Other Identifiers

2012-A00331-42

Identifier Type: -

Identifier Source: secondary_id

CHU-0131

Identifier Type: -

Identifier Source: org_study_id