Nutritional Status of Patients Victims of Haemorragic Accidents With Antivitamins K

NCT01742871 | Unknown

• 2 other identifiers: CHU-01312012-A00331-42
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Hemorrhagic Accident; Iatrogeny; Denutrition

Keywords

Antivitamin K; Bleeding; Haemorrhage; Nutritional status; impedancemetry

Outcome Measures

Primary Outcomes (1)

• Denutrition diagnosis

  at day 1

Secondary Outcomes (9)

• 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

Study Arms (2)

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 ®).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 33077273 DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 6, 2012
• Study Start: August 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: December 6, 2012

Record last verified: 2012-12

Locations

FR (1)