Clinical trial NCT01742871: Nutritional Status of Patients Victims of Haemorragic Accidents With Antivitamins K
Official title: Nutritional Status of Patients Victims of Haemorragic Accidents With Antivitamins K
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemorrhagic Accident
Iatrogeny
Denutrition
Keywords: Antivitamin K
Bleeding
Haemorrhage
Nutritional status
impedancemetry
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Be included in this study patients under anti-vitamin K supported or followed the emergency department Adults.

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

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

Primary outcomes:
measure: Denutrition diagnosis
timeFrame: at day 1
Secondary outcomes:
measure: Zinc blood level
timeFrame: at day 1
measure: Cupper blood level
timeFrame: at day 1
measure: vitamin C blood level
timeFrame: at day 1
measure: vitamin B1 blood level
timeFrame: at day 1
measure: PINI (pronostic inflammatory and nutritional index)
timeFrame: at day 1
measure: NRI (nutritional risk index)
timeFrame: at day 1
measure: The outpatient bleeding risk index
timeFrame: at day 1
measure: Stiffness index
timeFrame: at day 1
measure: Rumpel-Leede test
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
References:
citation: 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.