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Nutritional Status of Patients Victims of Haemorragic Accidents With Antivitamins K

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ClinicalTrials.gov Identifier: NCT01742871
Recruitment Status : Unknown
Verified December 2012 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : December 6, 2012
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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

Condition or disease
Hemorrhagic Accident Iatrogeny Denutrition

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


Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Nutritional Status of Patients Victims of Haemorragic Accidents With Antivitamins K
Study Start Date : August 2012
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

Group/Cohort
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 ®).



Primary Outcome Measures :
  1. Denutrition diagnosis [ Time Frame: at day 1 ]

Secondary Outcome Measures :
  1. Zinc blood level [ Time Frame: at day 1 ]
  2. Cupper blood level [ Time Frame: at day 1 ]
  3. vitamin C blood level [ Time Frame: at day 1 ]
  4. vitamin B1 blood level [ Time Frame: at day 1 ]
  5. PINI (pronostic inflammatory and nutritional index) [ Time Frame: at day 1 ]
  6. NRI (nutritional risk index) [ Time Frame: at day 1 ]
  7. The outpatient bleeding risk index [ Time Frame: at day 1 ]
  8. Stiffness index [ Time Frame: at day 1 ]
  9. Rumpel-Leede test [ Time Frame: at day 1 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01742871     History of Changes
Other Study ID Numbers: CHU-0131
2012-A00331-42
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012

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
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors