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Nutritional Status of Patients Victims of Haemorragic Accidents With Antivitamins K

Nutritional Status of Patients Victims of Haemorragic Accidents With Antivitamins K

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01742871
Enrollment
300
Registered
2012-12-06
Start date
2012-08-31
Completion date
2014-01-31
Last updated
2012-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Denutrition, Hemorrhagic Accident, Iatrogeny

Keywords

Antivitamin K, Bleeding, Haemorrhage, Nutritional status, impedancemetry

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

Interventions

None listed

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Denutrition diagnosisat day 1

Secondary

MeasureTime frame
Cupper blood levelat day 1
vitamin C blood levelat day 1
vitamin B1 blood levelat day 1
PINI (pronostic inflammatory and nutritional index)at day 1
Zinc blood levelat day 1
The outpatient bleeding risk indexat day 1
Stiffness indexat day 1
Rumpel-Leede testat day 1
NRI (nutritional risk index)at day 1

Countries

France

Contacts

Primary ContactPatrick LACARIN
placarin@chu-clermontferrand.fr04 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026