D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months (DODS)
12. december 2016 opdateret af: McMaster University
A Cohort Study to Test That There is a Low Risk of Recurrent VTE in Patients With a First Episode of Unprovoked VTE Who Stop Anticoagulant Therapy After 3 Months of Treatment in Response to Negative D-dimer Testing
The purpose of this study is to determine if the risk of recurrent venous thromboembolism (VTE) after stopping therapy is low and acceptable in patients with a first unprovoked proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) who have completed 3 months of therapy and who have a negative D-dimer test on therapy and 1 month after stopping therapy.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
410
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- McMaster University
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Hamilton, Ontario, Canada, L8L 2X2
- Hamilton General Hospital
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Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Health Care Centre
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Hamilton, Ontario, Canada, L8V1C3
- Henderson Hospital
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Cambridge, Det Forenede Kongerige, B2 0QQ
- Addenbrooke's Hospital
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20057
- Lombardi Cancer Center
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Hospitals and Clinics
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Forenede Stater, 02215
- Beth Israel Deaconess Medical Centre
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599-7035
- UNC Thrombophilia Program
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Utah
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Murray, Utah, Forenede Stater, 84152
- Intermountain Medical Centre
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Limerick, Irland
- Limerick, Mid Western Regional Hospital
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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 til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Be >= 18 years of age
- Have had ONE episode of unprovoked proximal DVT and/or PE
- Have completed 3 uninterrupted months of warfarin therapy (target INR of 2.0-3.0)
Exclusion Criteria:
- Another indication for long-term anticoagulation (e.g., atrial fibrillation)
A high risk of bleeding as evidenced by any of the following:
- Age greater than 75 years
- Previous episode of major bleeding where the cause was not effectively treated
- Known chronic thrombocytopenia with a platelet count of less than 120,000 x 10^9 /L
- Known chronic renal impairment with a creatinine of more than 150 mumols /litre (1.7 mg/dl)
- Known chronic liver disease with a total bilirubin of more than 25 mumols /litre (1.5 mg/dl)
- Active peptic ulcer disease
- Poor compliance with, or control of, anticoagulant therapy during initial treatment
- Requires dual antiplatelet therapy (e.g. aspirin and clopidogrel)
- A vena caval filter
- Has had D-dimer testing performed within 2 months of potential enrollment other than for evaluation of suspected recurrent VTE that was not confirmed
- Has a life expectancy less than 5 years
- Is unable to attend follow-up visits because of geographic inaccessibility
- Is participating in a competing clinical investigation
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: No Anticoagulant Therapy
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Patients with negative d-dimer discontinue long-term anticoagulant therapy.
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Andet: Anticoagulant Therapy
Continue on anticoagulant therapy
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Patients with positive d-dimer continue or re-start on anticoagulant therapy
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Suspected Recurrent DVT
Tidsramme: up to 7 years
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up to 7 years
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Suspected (recurrent) pulmonary embolism
Tidsramme: up to 7 years
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up to 7 years
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Bleeding
Tidsramme: up to 7 years
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up to 7 years
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Death
Tidsramme: up to 7 years
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up to 7 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Clive Kearon, MB MRCP(I) FRCP(C) PhD, McMaster University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Kearon C, Parpia S, Spencer FA, Schulman S, Stevens SM, Shah V, Bauer KA, Douketis JD, Lentz SR, Kessler CM, Connors JM, Ginsberg JS, Spadafora L, Julian JA. Long-term risk of recurrence in patients with a first unprovoked venous thromboembolism managed according to d-dimer results; A cohort study. J Thromb Haemost. 2019 Jul;17(7):1144-1152. doi: 10.1111/jth.14458. Epub 2019 May 20.
- Kearon C, Parpia S, Spencer FA, Baglin T, Stevens SM, Bauer KA, Lentz SR, Kessler CM, Douketis JD, Moll S, Kaatz S, Schulman S, Connors JM, Ginsberg JS, Spadafora L, Bhagirath V, Liaw PC, Weitz JI, Julian JA. Antiphospholipid antibodies and recurrent thrombosis after a first unprovoked venous thromboembolism. Blood. 2018 May 10;131(19):2151-2160. doi: 10.1182/blood-2017-09-805689. Epub 2018 Feb 28.
- Kearon C, Spencer FA, O'Keeffe D, Parpia S, Schulman S, Baglin T, Stevens SM, Kaatz S, Bauer KA, Douketis JD, Lentz SR, Kessler CM, Moll S, Connors JM, Ginsberg JS, Spadafora L, Julian JA; D-dimer Optimal Duration Study Investigators. D-dimer testing to select patients with a first unprovoked venous thromboembolism who can stop anticoagulant therapy: a cohort study. Ann Intern Med. 2015 Jan 6;162(1):27-34. doi: 10.7326/M14-1275.
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. december 2016
Studieafslutning (Faktiske)
1. december 2016
Datoer for studieregistrering
Først indsendt
21. juli 2008
Først indsendt, der opfyldte QC-kriterier
21. juli 2008
Først opslået (Skøn)
23. juli 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. december 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. december 2016
Sidst verificeret
1. december 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CTMG-2007-DODS
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 .