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The Designer D-dimer Deep Vein Thrombosis Diagnosis (4D) Study (4D)

This study is currently recruiting participants.
Verified December 2016 by McMaster University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02038530
First Posted: January 16, 2014
Last Update Posted: December 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University
  Purpose
This is a cohort study that will assess a new diagnostic management strategy for suspected Deep Vein Thrombosis in outpatients.The new diagnostic strategy is designed to reduce the use of ultrasound testing on the day of presentation, and reduce repeat ultrasound testing a week after an initial normal test.

Condition Phase
Suspected Deep Vein Thrombosis Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: D-dimer Testing, Tailored to Clinical Pretest Probability, to Minimize Initial and Follow-up Ultrasound Imaging in Suspected Deep Vein Thrombosis: A Management Study

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Confirmed symptomatic proximal Deep Vein Thrombosis [ Time Frame: within 90 days ]
    The primary outcome is confirmed symptomatic proximal Deep Vein Thrombosis (including involvement of the calf vein trifurcation but not isolated more distal Deep Vein Thrombosis; or pulmonary embolism (not including isolated sub-segmental abnormalities on Computed Tomography Pulmonary Angiogram; within 90 days (± 7 days for follow-up assessment) that is not diagnosed by scheduled diagnostic testing (includes events that occur between initial and scheduled follow-up proximal ultrasound examinations).


Secondary Outcome Measures:
  • Clinical Pretest Probability/ D-dimer/ Compression Ultrasound subgroups [ Time Frame: within 90 days ]

    The primary outcome in the following subgroups:

    • Low Clinical Pretest Probability and D-dimer <1000 ug/L
    • Moderate Clinical Pretest Probability and D-dimer <500 ug/L
    • Moderate Clinical Pretest Probability and D-dimer 500 -999 ug/L
    • High Clinical Pretest Probability and D-dimer <500 ug/L
    • Low Clinical Pretest Probability and D-dimer 1000-2999 ug/L and negative initial ultrasound
    • Moderate Clinical Pretest Probability and D-dimer 1000-2999 ug/L and negative initial ultrasound
    • High Clinical Pretest Probability and D-dimer 500-1499 ug/L and negative initial ultrasound

  • Death [ Time Frame: within 90 days ]
    Death within 90 days (± 7 days for follow-up assessment).


Estimated Enrollment: 1500
Study Start Date: February 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
No Ultrasound
Low Clinical Pretest Probability and D-dimer < 1000 ug/L; Moderate Clinical Pretest Probability and D-dimer < 500 ug/L
Ultrasound Required
Low Clinical Pretest Probability and D-dimer 1000 - 3000 ug/L; Moderate Clinical Pretest Probability and D-dimer 500 - 3000 ug/L; High Clinical Pretest Probability

Detailed Description:
This is a prospective, multicentre, cohort study that will assess a new diagnostic management strategy for suspected Deep Vein Thrombosis in outpatients. The new diagnostic strategy is designed to reduce the use of ultrasound testing on the day of presentation, and reduce repeat ultrasound testing a week after an initial normal test. Less ultrasound testing will be performed because: i) more patients will have deep vein thrombosis excluded by combinations of Clinical Pretest Probability and D-dimer results on the day of presentation; and, ii) in those who still need an ultrasound, a repeat ultrasound a week after a normal result will only be performed if the D-dimer result is markedly abnormal at initial presentation. The safety of this management strategy will be established by demonstrating a very low rate of proximal Deep Vein Thrombosis or Pulmonary Embolism during 90 days follow-up in patients who had anticoagulant therapy withheld in response to negative diagnostic testing. Diagnostic test utilization will be assessed. All clinical outcomes will be adjudicated by a central independent adjudication committee that will be blind to initial D-dimer measurements and patient management.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male and females outpatients with a suspected Deep Vein Thrombosis
Criteria

Inclusion Criteria:

1) Consecutive outpatients (i.e. non-hospitalized patients) with clinically suspected Deep Vein Thrombosis.

Exclusion Criteria:

  1. Age less than 18 years.
  2. Treated with full-dose anticoagulation for ≥ 24 hours before D-dimer was measured.
  3. D-dimer level known before Clinical Pretest Probability documented.
  4. Ultrasound of the leg performed before Clinical Pretest Probability was documented
  5. Ultrasound was or will be performed in a patient with low Clinical Pretest Probability and a d-dimer <1000(or equivalent), or with Moderate Clinical Pretest Probability and a D-dimer <500 (or equivalent) (e.g. suspected bleeding).
  6. Ongoing need for anticoagulant therapy.
  7. Suspected Pulmonary Embolism.
  8. Superficial venous thrombosis that requires, or may require, anticoagulant therapy.
  9. Life expectancy less than 3 months.
  10. Previously confirmed episode of Deep Vein Thrombosis.
  11. Geographic inaccessibility which precludes follow-up.
  12. Known pregnancy.
  Contacts and Locations
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): NCT02038530


Contacts
Contact: Luciana Spadafora 905-527-2299 ext 42655 spadafl@mcmaster.ca
Contact: Lisa N Rudd-Scott, RN BScN MN 905-527-2299 ext 43793 ruddl@mcmaster.ca

Locations
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Cynthia Wu, M.D.    780-492-3980    cwu@ualberta.ca   
Contact: Patricia Bellot    780-492-3980    bellot@ualberta.ca   
Principal Investigator: Cythia Wu, M.D.         
Sub-Investigator: Lauren Bolster, M.D.         
Sub-Investigator: Joseph Brandwein, M.D.         
Sub-Investigator: Marlene Hamilton, M.D.         
Sub-Investigator: Loree Larratt, M.D.         
Sub-Investigator: Jeffery Patterson, M.D.         
Sub-Investigator: Anthea Peters, M.D.         
Sub-Investigator: Bruce Ritchie, M.D.         
Sub-Investigator: Lalit Saini, M.D.         
Sub-Investigator: Irwindeep Sandhu, M.D.         
Sub-Investigator: Minakshi Taparia, M.D.         
Sub-Investigator: Nancy Zhu, M.D.         
Canada, Nova Scotia
Nova Scotia Cancer Centre Recruiting
Halifax, Nova Scotia, Canada, B3H1V7
Contact: Sudeep Shivakumar, MD    902-473-7006    sudeep.shivakumar@cdha.nshealth.ca   
Contact: Blaine Gallant, RN    902-473-1399    blaine.gallant@cdha.nshealth.ca   
Principal Investigator: Sudeep Shivakumar, MD         
Sub-Investigator: David Anderson, MD         
Sub-Investigator: Samuel Campbell, MD         
Canada, Ontario
Hamilton Health Sciences - Hamilton General Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Michelle Zondag, RN    905-527-4322 ext 44807    zondagm@hhsc.ca   
Contact: Alla Glushchenko    905-527-4322 ext 43784    glushcha@mcmaster.ca   
Principal Investigator: Sam Schulman, MD         
Sub-Investigator: John Eikelboom, MD         
Hamilton Health Sciences - McMaster Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Shannon M Bates, MD    905-521-2100 ext 73928    batesm@mcmaster.ca   
Contact: Laurie Sardo, RN    905-521-2100 ext 76984    sardola@mcmaster.ca   
Principal Investigator: Shannon M Bates, MD         
St. Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Fred Spencer, M.D.    905-522-1155 ext 33353    fspence@mcmaster.ca   
Contact: Sandra Messier    905-522-1155 ext 33260    smessier@stjosham.on.ca   
Principal Investigator: Fred Spencer, M.D.         
Sub-Investigator: Peter Powers, M.D.         
Sub-Investigator: Jovana Yudin, M.D.         
Juravinski Cancer Hospital Recruiting
Ham, Ontario, Canada, L8V1C3
Contact: Pam Stevens, RN    905-521-2100 ext 43784    stevensp@mcmaster.ca   
Principal Investigator: Clive Kearon, MD         
Sub-Investigator: Shannon M Bates, MD         
Sub-Investigator: Peter L Gross, MD         
Sub-Investigator: Alfanzo Iorio, MD         
Sub-Investigator: Lori-Ann Linkins, MD         
Sub-Investigator: Sarah Takach-Lapner, MD         
Sub-Investigator: Jeff Weitz, MD         
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Alejandro Lazo-Langner, M.D.    519-685-8500 ext 58833    alejandro.lazolangner@lhsc.on.ca   
Contact: LulJeta Pallaveshi    519-685-8500 ext 55148    luli.pallaveshi@sjhc.london.on.ca   
Sub-Investigator: Johnathan Dreyer, MD         
Sub-Investigator: Michael Kovacs, MD         
Sub-Investigator: Martha Louzada, MD         
Sub-Investigator: Ramesh Reddy, MD         
The Ottawa Hospital Regional Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Gregoire Le Gal, M.D.    613-737-8899 ext 73034    glegal@ohri.ca   
Contact: Holly Carr    613-737-8899 ext 73301    hcarr@ohri.ca   
Principal Investigator: Gregoire Le Gal, M.D.         
Sub-Investigator: Marc Carrier, M.D.         
Sub-Investigator: Lana Castellucci, M.D.         
Sub-Investigator: Cathy Code, M.D.         
Sub-Investigator: Lisa Duffett, M.D.         
Sub-Investigator: Melissa Forgie, M.D.         
Sub-Investigator: Esteban Gandara, M.D.         
Sub-Investigator: Carol Gonsalves, M.D.         
Sub-Investigator: Alan Karovitch, M.D.         
Sub-Investigator: Marc Rodger, M.D.         
Sub-Investigator: Terry Saunders-Smith, M.D.         
Sub-Investigator: Dimitrios Scarvelis, M.D.         
Sub-Investigator: Phil Wells, M.D.         
Canada, Quebec
The Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Marc Afilalo, M.D.    514-340-8222 ext 5568    marc.afilalo@mcgill.ca   
Contact: Chris Tselios    514-340-8222 ext 3852    christos.tselios@mail.mcgill.ca   
Principal Investigator: Marc Afilalo, M.D.         
Sub-Investigator: Susan Kahn, M.D.         
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Clive Kearon, MD OCOG
  More Information

Additional Information:
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02038530     History of Changes
Other Study ID Numbers: OCOG-2013-4D
First Submitted: January 13, 2014
First Posted: January 16, 2014
Last Update Posted: December 13, 2016
Last Verified: December 2016

Keywords provided by McMaster University:
Deep Vein Thrombosis

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fibrin fragment D
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants