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Predicting Bleeding Risk on Anticoagulant Therapy for Venous Thromboembolism

25. oktober 2016 opdateret af: Ottawa Hospital Research Institute

Development and Validation of Clinical Prediction Rules for Bleeding for Patients on Anticoagulant Therapy for Venous Thromboembolism

The main objective of the study is to develop or validate a clinical prediction rule for major bleeding in patients on oral anticoagulant therapy who have been safely anticoagulated without bleeding or venous thromboembolism (VTE) recurrence for at least 3 months since diagnosis and are being considered for long-term oral anticoagulant therapy.

Studieoversigt

Status

Afsluttet

Betingelser

Venøs tromboembolisme

Detaljeret beskrivelse

Oral anticoagulant therapy for patients who are at risk of developing blood clotting problems is used by between 400,000-600,000 Canadians annually. The use of this drug represents the most common cause of patient adverse medical outcomes due to medical errors. Furthermore, many patients have adverse outcomes using these drugs because physicians are not able to predict which patients are likely to have bleeding outcomes. Much effort has gone into developing ways to predict which patients are at risk of clotting but almost no work has gone into ways of predicting which patients would be at high risk of bleeding. This information is required to balance off the risk-benefits and to enable physicians and patients to understand the risks and benefits of taking these medications. Our study will develop a tool that can be used to predict bleeding risk in patients taking oral anticoagulant therapy. It will enable more informed decision making by both physicians and patients and will result in better control of the use of these drugs. In addition, patients who are at risk for being difficult to accurately dose on oral anticoagulants will be identified through our study.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

2537

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Canada
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - Queen Elizabeth Ii Health Sciences Centre
- Ontario
  - Hamilton, Ontario, Canada, L8L 2X2
    - Hamilton General Hospital
  - Hamilton, Ontario, Canada, L8V 1C3
    - Hamilton Health Sciences
  - London, Ontario, Canada, N6A 4G5
    - London Health Sciences Centre
  - Ottawa, Ontario, Canada, K1H 8L6
    - Ottawa Hospital Research Institute
- Quebec
  - Montreal, Quebec, Canada, H3G 1A4
    - Montreal General Hospital
  - Montreal, Quebec, Canada, H4J 1C5
    - Hopital Du Sacre Coeur de Montreal
  - Montreal, Quebec, Canada, H3T 1E2
    - Sir Mortimer B Davis Jewish General Hospital
  - Montreal, Quebec, Canada, H3T 1M5
    - St. Mary's Hospital Centre
Det Forenede Kongerige
- - Oxford, Det Forenede Kongerige, 0X3 7LJ
    - Oxford Haemophilia and Thrombosis Centre, Churchill Hospital
Forenede Stater
- Massachusetts
  - Burlington, Massachusetts, Forenede Stater, MA01805
    - Lahey Clinic
- Michigan
  - Detroit, Michigan, Forenede Stater, 48202
    - Henry Ford Health System

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Outpatients being treated for venous thromboembolism

Beskrivelse

Inclusion Criteria:

>=18 years old
provoked or unprovoked venous thromboembolism
objectively confirmed venous thromboembolism
treated with an oral anticoagulant(vitamin K antagonist or new oral anticoagulant) for at least 3 months with plans to continue long-term
if taking a vitamin K antagonist; INR target is between 2.0-3.0
if taking a vitamin K antagonist; must have taken it for the last 3 consecutive weeks (minimum)

Exclusion Criteria:

major bleeding while taking oral anticoagulants
active bleeding at study enrollment
active cancer - current or at the time of VTE diagnosis
unable to provide written informed consent
refusal to provide written informed consent

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
Major bleeding (International Society on Thrombosis and Haemostasis(ISTH) criteria) Tidsramme: ongoing for 3-7 years with follow-up phone calls at 6-month intervals	ongoing for 3-7 years with follow-up phone calls at 6-month intervals

Sekundære resultatmål

Resultatmål	Tidsramme
Clinically relevant non-major bleeding (International Society on Thrombosis and Haemostasis(ISTH) criteria) Tidsramme: ongoing for 3-7 years with follow-up phone calls at 6-month intervals	ongoing for 3-7 years with follow-up phone calls at 6-month intervals
recurrent venous thromboembolism Tidsramme: ongoing for 3-7 years with follow-up phone calls at 6-month intervals	ongoing for 3-7 years with follow-up phone calls at 6-month intervals
death (all causes) Tidsramme: ongoing for 3-7 years with follow-up phone calls at 6-month intervals	ongoing for 3-7 years with follow-up phone calls at 6-month intervals

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ottawa Hospital Research Institute

Samarbejdspartnere

Canadian Institutes of Health Research (CIHR)

Heart and Stroke Foundation of Ontario

Efterforskere

Ledende efterforsker: Phil S Wells, MD, MSc, Ottawa Hospital Research Institute

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2008

Primær færdiggørelse (Faktiske)

1. september 2016

Studieafslutning (Faktiske)

1. oktober 2016

Datoer for studieregistrering

Først indsendt

10. november 2008

Først indsendt, der opfyldte QC-kriterier