NCT02384135

Brief Summary

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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
3 countries

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

October 1, 2018

Status Verified

September 1, 2018

Enrollment Period

4.4 years

First QC Date

February 25, 2015

Last Update Submit

September 28, 2018

Conditions

Deep Vein ThrombosisD-dimer

Outcome Measures

Primary Outcomes (1)

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

    three-month follow-up

Study Arms (1)

interventional

OTHER

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

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Foothills Medical Centre

Calgary, Calgary/Alberta, Canada

RECRUITING

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

Hôpital Monfort

Monfort, Ontario, Canada

RECRUITING

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

RECRUITING

Royal University Hospital

Saskatoon, Saskatchewan, Canada

RECRUITING

Providence Health Care

Vancouver, Vancouver/British Columbia, Canada

NOT YET RECRUITING

Kingston General Hospital

Kingston, Ontario, Canada

RECRUITING

The Ottawa Hospital

Ottawa, Canada

RECRUITING

Thunder Bay regional Health Sciences center

Thunder Bay, Ontario, Canada

NOT YET RECRUITING

University Health network

Toronto, Ontario, Canada

RECRUITING

Grégoire LE GAL

Brest, 29609, France

RECRUITING

Marc Righini

Geneva, 1205, Switzerland

RECRUITING

Geneva University Hospital

Geneva, 1211, Switzerland

RECRUITING

University Hospital of Geneva

Geneva, Switzerland

RECRUITING

Related Publications (1)

  • Le Gal G, Robert-Ebadi H, Thiruganasambandamoorthy V, Moustafa F, Penaloza A, Catella J, Grenot MC, Visser S, Mazzolai L, Plumacker A, Barco S, Lang E, Tagalakis V, Deroche C, Garnett M, Hulme J, Roy PM, Ghuysen A, Couturaud F, Engelberger R, El Kouri D, Aujesky D, Righini M; ADJUST-DVT Investigators. Age-Adjusted D-Dimer Cutoff Levels to Rule Out Deep Vein Thrombosis. JAMA. 2026 Jan 5:e2521561. doi: 10.1001/jama.2025.21561. Online ahead of print.

    PMID: 41490105DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Marc Righini, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

  • Grégoire Le Gal, MD

    Ottawa University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Righini, MD

CONTACT

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

Louise Riberdy, Nurse

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

February 25, 2015

First Posted

March 10, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2019

Study Completion

October 1, 2019

Last Updated

October 1, 2018

Record last verified: 2018-09

Locations

CA(11)FR(1)CH(3)