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Nutritional Status of Patients Victims of Haemorragic Accidents With Antivitamins K

This study is currently recruiting participants.
Verified December 2012 by University Hospital, Clermont-Ferrand
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01742871
First received: December 4, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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


Condition
Hemorrhagic Accident
Iatrogeny
Denutrition

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Nutritional Status of Patients Victims of Haemorragic Accidents With Antivitamins K

Resource links provided by NLM:

MedlinePlus related topics: Vitamin K
U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Denutrition diagnosis [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Zinc blood level [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • Cupper blood level [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • vitamin C blood level [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • vitamin B1 blood level [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • PINI (pronostic inflammatory and nutritional index) [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • NRI (nutritional risk index) [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • The outpatient bleeding risk index [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • Stiffness index [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • Rumpel-Leede test [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: August 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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 ®).

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742871

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN     04 73 75 11 95     placarin@chu-clermontferrand.fr    
Principal Investigator: Jeannot SCHMIDT            
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01742871     History of Changes
Other Study ID Numbers: CHU-0131, 2012-A00331-42
Study First Received: December 4, 2012
Last Updated: December 4, 2012
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Antivitamin K
Bleeding
Haemorrhage
Nutritional status
impedancemetry

Additional relevant MeSH terms:
Antivitamins K
4-Hydroxycoumarins
Vitamin K
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013