Recruiting

Observational Study

Sponsor:

University Hospital, Geneva

Code:

NCT02384135

Conditions

Deep Vein Thrombosis

D-dimer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Three-month thromboembolic risk in patient with D-dimer levels between the usual cut-off and the age-adjusted cut-off

Study Details

Brief summary:

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

Conditions

Deep Vein Thrombosis

D-dimer

Study ID

NCT02384135

Start date

Mar, 2015

Status verified date

Sep, 2018

Completion date

Oct, 2019

Anticipated

Primary completion date

Aug, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

3300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: 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

Interventions

Three-month thromboembolic risk in patient with D-dimer levels between the usual cut-off and the age-adjusted cut-off

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Marc Righini, MD

+41 22 372 92 94marc.righini@hcuge.ch

Louise Riberdy, Nurse

+41 22 372 92 92louise.riberdy@hcuge.ch

Locations

Foothills Medical Centre

Recruiting

Calgary, Calgary/Alberta, Canada

Contacts

Eddy Lang, MD

Eddy.Lang@albertahealthservices.ca

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Sam Schulman, MD

905-527-0271schulms@mcmaster.ca

Principal Investigator:

Sam Schulman, MD

HĂ´pital Monfort

Recruiting

Monfort, Ontario, Canada

Contacts

Shaun Visser, MD

shaunvisser@monfort.on.ca

Hopital Maisonneuve-Rosemont

Recruiting

Montreal, Quebec, Canada

Contacts

Jeannine Kassis, MD

jkassis@ssss.gouv.qc.ca

Principal Investigator:

Jeannine Kassis, MD

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada

Contacts

Susan Kahn, MD

514-340-8222susan.kahn@mcgill.ca

Principal Investigator:

Susan Kahn, MD

Royal University Hospital

Recruiting

Saskatoon, Saskatchewan, Canada

Contacts

Otto Moodley, MD

omoodley@saskcancer.ca

Principal Investigator:

Otto Moodley, MD

Kingston General Hospital

Recruiting

Kingston, Ontario, Canada

Contacts

Colin Bell, MD

colin.bell@queensu.ca

The Ottawa Hospital

Recruiting

Ottawa, Canada

Contacts

Grégoire Le Gal, MD, PhD

glegal@toh.ca

University Health network

Recruiting

Toronto, Ontario, Canada

Contacts

Jennifer Hulme, MD

Jennifer.hulme@uhn.ca

More Information

Sponsor

University Hospital, Geneva

Last update posted

Oct 1, 2018

Last verified

Sep, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospital, Geneva on 2018-10-01.