Understanding Risk Factors Involved in Developing a Second Blood Clot.

NCT00261014 | Unknown

• 1 other identifier: 2002452-01H
• Study Type: observational
• Target: 800
• Locations: 2 countries
• Sites: 7

Brief Summary

The purpose of this study is to develop a way to predict which patients diagnosed with idiopathic blood clots can safely stop warfarin therapy after six months. We will use patient characteristics, blood test results and imaging test results to identify those patients who have the lowest risk of developing a new blood clot after warfarin is stopped.

Conditions

Deep Vein Thrombosis

Keywords

Recurrent; Idiopathic; Deep Vein Thrombosis; Pulmonary Embolism; Clinical Prediction Rule; Venous Thromboembolism; Risk Factors

Outcome Measures

Primary Outcomes (1)

• Incidence of adjudicated recurrent VTE during study follow-up

  8 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with idiopathic blood clots

You may qualify if:

• Objectively proven (as previously described (8)) proximal idiopathic deep vein thrombosis or pulmonary embolism. Idiopathic will be defined as VTE occurring in the absence of fracture, plaster cast, immobilization greater than 3 days or a general anesthetic in the last three months prior to VTE diagnosis; a known deficiency of antithrombin, protein C or protein S; and malignancy in the last five years
• Patients treated initially with a minimum of five days of heparin or low molecular weight heparin and oral anticoagulants with a target intensity of 2.0 - 3.0 with no recurrence in the subsequent six months.
• Patients currently on oral anticoagulants

You may not qualify if:

• Age \<18;
• Known deficiency of proteins S, protein C or antithrombin;
• Known, persistently positive anticardiolipin antibodies (titers \> 30U/ml);
• Known, persistently positive lupus anticoagulant;
• Combined thrombophilic defects (e.g. homozygous for FVL or PGM, or compound heterozygous for FVL and PGM);
• Refusal of informed consent.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Biomerieux inc: collaborator
• Heart and Stroke Foundation of Ontario: collaborator

Study Sites (7)

QE II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Montreal Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Hopital du Sacre Coeur

Montreal, Quebec, H4J 1C5, Canada

Location

CHU de le Cavale Blanche

Brest, France

Location

Related Publications (7)

• Wan T, Rodger M, Zeng W, Robin P, Righini M, Kovacs MJ, Tan M, Carrier M, Kahn SR, Wells PS, Anderson DR, Chagnon I, Solymoss S, Crowther M, White RH, Vickars L, Bazarjani S, Le Gal G. Residual pulmonary embolism as a predictor for recurrence after a first unprovoked episode: Results from the REVERSE cohort study. Thromb Res. 2018 Feb;162:104-109. doi: 10.1016/j.thromres.2017.11.020. Epub 2017 Dec 8.

  PMID: 29224973 DERIVED

• Rodger MA, Scarvelis D, Kahn SR, Wells PS, Anderson DA, Chagnon I, Le Gal G, Gandara E, Solymoss S, Sabri E, Kovacs J, Kovacs MJ. Long-term risk of venous thrombosis after stopping anticoagulants for a first unprovoked event: A multi-national cohort. Thromb Res. 2016 Jul;143:152-8. doi: 10.1016/j.thromres.2016.03.028. Epub 2016 Mar 29.

  PMID: 27086275 DERIVED

• Galanaud JP, Holcroft CA, Rodger MA, Kovacs MJ, Betancourt MT, Wells PS, Anderson DR, Chagnon I, Le Gal G, Solymoss S, Crowther MA, Perrier A, White RH, Vickars LM, Ramsay T, Kahn SR. Predictors of post-thrombotic syndrome in a population with a first deep vein thrombosis and no primary venous insufficiency. J Thromb Haemost. 2013 Mar;11(3):474-80. doi: 10.1111/jth.12106.

  PMID: 23279046 DERIVED

• Galanaud JP, Holcroft CA, Rodger MA, Kovacs MJ, Betancourt MT, Wells PS, Anderson DR, Chagnon I, Le Gal G, Solymoss S, Crowther MA, Perrier A, White RH, Vickars LM, Ramsay T, Kahn SR. Comparison of the Villalta post-thrombotic syndrome score in the ipsilateral vs. contralateral leg after a first unprovoked deep vein thrombosis. J Thromb Haemost. 2012 Jun;10(6):1036-42. doi: 10.1111/j.1538-7836.2012.04713.x.

  PMID: 22646832 DERIVED

• Kovacs MJ, Kahn SR, Wells PS, Anderson DA, Chagnon I, LE Gal G, Solymoss S, Crowther M, Perrier A, Ramsay T, Betancourt MT, White RH, Vickars L, Rodger MA. Patients with a first symptomatic unprovoked deep vein thrombosis are at higher risk of recurrent venous thromboembolism than patients with a first unprovoked pulmonary embolism. J Thromb Haemost. 2010 Sep;8(9):1926-32. doi: 10.1111/j.1538-7836.2010.03958.x.

  PMID: 20561184 DERIVED

• Le Gal G, Kovacs MJ, Carrier M, Do K, Kahn SR, Wells PS, Anderson DA, Chagnon I, Solymoss S, Crowther M, Righini M, Perrier A, White RH, Vickars L, Rodger M. Validation of a diagnostic approach to exclude recurrent venous thromboembolism. J Thromb Haemost. 2009 May;7(5):752-9. doi: 10.1111/j.1538-7836.2009.03324.x. Epub 2009 Feb 18.

  PMID: 19228281 DERIVED

• Rodger MA, Kahn SR, Wells PS, Anderson DA, Chagnon I, Le Gal G, Solymoss S, Crowther M, Perrier A, White R, Vickars L, Ramsay T, Betancourt MT, Kovacs MJ. Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy. CMAJ. 2008 Aug 26;179(5):417-26. doi: 10.1503/cmaj.080493.

  PMID: 18725614 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Recurrence; Pulmonary Embolism; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Embolism; Thromboembolism

Study Officials

• Marc Rodger, MD MSc

  OHRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2005
• First Posted: December 2, 2005
• Study Start: October 1, 2002
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

FR (1); CA (6)