- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01742871
Nutritional Status of Patients Victims of Haemorragic Accidents With Antivitamins K
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
-
Clermont-Ferrand, Frankrig, 63003
- Rekruttering
- Chu Clermont-Ferrand
-
Ledende efterforsker:
- Jeannot SCHMIDT
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Tværsnit
Kohorter og interventioner
Gruppe / kohorte |
---|
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 ®).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Denutrition diagnosis
Tidsramme: at day 1
|
at day 1
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Zinc blood level
Tidsramme: at day 1
|
at day 1
|
Cupper blood level
Tidsramme: at day 1
|
at day 1
|
vitamin C blood level
Tidsramme: at day 1
|
at day 1
|
vitamin B1 blood level
Tidsramme: at day 1
|
at day 1
|
PINI (pronostic inflammatory and nutritional index)
Tidsramme: at day 1
|
at day 1
|
NRI (nutritional risk index)
Tidsramme: at day 1
|
at day 1
|
The outpatient bleeding risk index
Tidsramme: at day 1
|
at day 1
|
Stiffness index
Tidsramme: at day 1
|
at day 1
|
Rumpel-Leede test
Tidsramme: at day 1
|
at day 1
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CHU-0131
- 2012-A00331-42
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Hemorrhagic Accident
-
University of Southern CaliforniaRekrutteringSlag | CVA (Cerebrovaskulær Accident)Forenede Stater
-
Toronto Rehabilitation InstituteUniversity of Toronto; Heart and Stroke Foundation of CanadaRekruttering
-
VA Office of Research and DevelopmentAktiv, ikke rekrutterendeCVA (Cerebrovaskulær Accident)Forenede Stater
-
Ahmed AnwarRekrutteringCVA (Cerebrovaskulær Accident)Egypten
-
University of Southern CaliforniaRekrutteringCVA (Cerebrovaskulær Accident)Forenede Stater
-
Florida Gulf Coast UniversityAfsluttetSlag | CVA (Cerebrovaskulær Accident)
-
Cairo UniversityBatterjee Medical CollegeAktiv, ikke rekrutterende
-
MyomoAfsluttetCVA (Cerebrovaskulær Accident)Forenede Stater
-
Chinese University of Hong KongQueen Mary Hospital, Hong Kong; Princess Margaret Hospital, Canada; Tuen... og andre samarbejdspartnereIkke rekrutterer endnuCVA (Cerebrovaskulær Accident)Hong Kong
-
Reuth Rehabilitation HospitalRekrutteringParese | CVA (Cerebrovaskulær Accident)Israel