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Age-adjusted D-dimer Cutoff Levels to Rule Out Deep Vein Thrombosis: a Prospective Outcome Study (ADJUST-DVT)

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ClinicalTrials.gov Identifier: NCT02384135
Recruitment Status : Recruiting
First Posted : March 10, 2015
Last Update Posted : October 1, 2018
Sponsor:
Collaborators:
The Ottawa Hospital
University Medical Center Groningen
Information provided by (Responsible Party):
Marc Righini, University Hospital, Geneva

Brief Summary:
Prospective validation of an age-adjusted D-dimer cut-off to rule out deep vein thrombosis (DVT)

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis D-dimer Other: Three-month thromboembolic risk in patient with D-dimer levels between the usual cut-off and the age-adjusted cut-off Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Age-adjusted D-dimer Cutoff Levels to Rule Out Deep Vein Thrombosis: a Prospective Outcome Study
Actual Study Start Date : March 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
interventional
Patients with D-dimer levels between the usual cutoff and the age-adjusted cutoff will be left untreated and followed-up for three months
Other: Three-month thromboembolic risk in patient with D-dimer levels between the usual cut-off and the age-adjusted cut-off



Primary Outcome Measures :
  1. Three-month thromboembolic risk in patient with D-dimer levels between the usual cut-off and the age-adjusted cut-off [ Time Frame: three-month follow-up ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All outpatients admitted to the emergency ward for suspected DVT will be included in the study, provided they correspond to the following diagnostic and exclusion criteria and they have signed an informed consent form.

Exclusion Criteria:

  • DVT suspicion raised more than 48 hours after admission to the hospital
  • Pregnancy.
  • Patients anticoagulated for a disease other than venous thromboembolism (for instance, atrial fibrillation)
  • Concommitant PE suspicion
  • Life expectancy less than 3 months
  • Absence of informed consent
  • Incapacity to deliver informed consent

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): NCT02384135


Contacts
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Contact: Marc Righini, MD +41 22 372 92 94 marc.righini@hcuge.ch
Contact: Louise Riberdy, Nurse +41 22 372 92 92 louise.riberdy@hcuge.ch

Locations
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Canada, Calgary/Alberta
Foothills Medical Centre Recruiting
Calgary, Calgary/Alberta, Canada
Contact: Eddy Lang, MD       Eddy.Lang@albertahealthservices.ca   
Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Sam Schulman, MD    905-527-0271 ext 44479    schulms@mcmaster.ca   
Principal Investigator: Sam Schulman, MD         
Hôpital Monfort Recruiting
Monfort, Ontario, Canada
Contact: Shaun Visser, MD       shaunvisser@monfort.on.ca   
Canada, Quebec
Hopital Maisonneuve-Rosemont Recruiting
Montreal, Quebec, Canada
Contact: Jeannine Kassis, MD       jkassis@ssss.gouv.qc.ca   
Principal Investigator: Jeannine Kassis, MD         
Jewish General Hospital Recruiting
Montreal, Quebec, Canada
Contact: Susan Kahn, MD    514-340-8222 ext 4667    susan.kahn@mcgill.ca   
Principal Investigator: Susan Kahn, MD         
Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada
Contact: Otto Moodley, MD       omoodley@saskcancer.ca   
Principal Investigator: Otto Moodley, MD         
Canada, Vancouver/British Columbia
Providence Health Care Not yet recruiting
Vancouver, Vancouver/British Columbia, Canada
Contact: Robert Stenstrom, MD       Rob.Stenstrom@ubc.ca   
Canada
Kingston General Hospital Recruiting
Kingston, Ontario, Canada
Contact: Colin Bell, MD       colin.bell@queensu.ca   
The Ottawa Hospital Recruiting
Ottawa, Canada
Contact: Grégoire Le Gal, MD, PhD       glegal@toh.ca   
Thunder Bay regional Health Sciences center Not yet recruiting
Thunder Bay, Ontario, Canada
Contact: Meghan Garnett, MD       mgarnett@nosm.ca   
University Health network Recruiting
Toronto, Ontario, Canada
Contact: Jennifer Hulme, MD       Jennifer.hulme@uhn.ca   
France
Grégoire LE GAL Recruiting
Brest, France, 29609
Contact: Grégoire LE GAL, PUPH    298347336 ext +33    gregoire.legal@chu-brest.fr   
Switzerland
Marc Righini Recruiting
Geneva, Switzerland, 1205
Contact: Marc Righini, MD       marc.righini@hcuge.ch   
Geneva University Hospital Recruiting
Geneva, Switzerland, 1211
Contact: Marc Righini, MD    +41 22 372 92 94    marc.righini@hcuge.ch   
Contact: Louise Riberdy, Nurse    +41 22 372 92 92    louise.riberdy@hcuge.ch   
Principal Investigator: Grégoire Le Gal, MD         
University Hospital of Geneva Recruiting
Geneva, Switzerland
Contact: Marc Righini, MD    0041 22 372 92 94    marc.righini@hcuge.ch   
Principal Investigator: Marc Righini, MD         
Sponsors and Collaborators
University Hospital, Geneva
The Ottawa Hospital
University Medical Center Groningen
Investigators
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Principal Investigator: Marc Righini, MD University Hospital, Geneva
Principal Investigator: Grégoire Le Gal, MD Ottawa University Hospital

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Responsible Party: Marc Righini, Prof, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02384135     History of Changes
Other Study ID Numbers: 14-191
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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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