NCT03634124

Brief Summary

The numerical ratio between the value of the thrombin generation test performed without soluble thrombomodulin and the value of the thrombin generation test performed in the presence of soluble thrombomodulin, performed pre-surgically, could predict the risk of early venous thromboembolism after placement of total hip or knee prosthesis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2019

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

August 7, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

February 21, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2023

Completed
Last Updated

February 11, 2026

Status Verified

November 1, 2023

Enrollment Period

4 years

First QC Date

August 7, 2018

Last Update Submit

February 9, 2026

Conditions

Total Hip ProsthesisKnee ProsthesisDeep Vein Thrombosis

Outcome Measures

Primary Outcomes (4)

  • Estimate the numerical ratio between the value of the thrombin generation test performed without soluble thrombomodulin and the value of the thrombin generation test performed in the presence of soluble thrombomodulin

    Numerical value

    Day 0

  • Occurrence of Symptomatic pulmonary embolism

    yes/non

    Day 7 (± 2)

  • Occurrence of Symptomatic deep vein thrombosis somewhere in the body

    Yes/no

    Day 7 (± 2)

  • Occurrence of Symptomatic deep vein thrombosis in legs

    Yes/non

    Day 7 (± 2)

Secondary Outcomes (8)

  • Occurrence of proximal Symptomatic deep vein thrombosis in legs

    Day 7 (± 2)

  • Occurrence of distal Symptomatic deep vein thrombosis in legs

    Day 7 (± 2)

  • Occurrence of muscular Symptomatic deep vein thrombosis in legs

    Day 7 (± 2)

  • Occurrence of any kind of Symptomatic deep vein thrombosis in legs except muscular

    Day 7 (± 2)

  • Occurrence of proximal asymptomatic deep vein thrombosis in legs by doppler ultrasound

    Day 7 (± 2)

  • +3 more secondary outcomes

Study Arms (1)

interventional group

EXPERIMENTAL
Biological: Blood testOther: Doppler ultrasound

Interventions

Blood testBIOLOGICAL

Additional blood test of 4,5 ml of venous blood

interventional group
Doppler ultrasoundOTHER

Vascular ultrasonic vascular exploration of the lower limbs

interventional group

Eligibility Criteria

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

You may qualify if:

  • The patient must have his consent and signed the consent form.
  • The patient must affiliated or a beneficiary of a health insurance plan.
  • The patient is at least 18 years old
  • Patient with an indication of total hip prosthesis or total knee replacement surgery set unilateral

You may not qualify if:

  • The patient is participating in another interventional study.
  • Minor patients, people in emergency situations.
  • The patient is under the protection of justice, guardianship or curatorship.
  • The patient refuses to sign the consent.
  • It is not possible to inform the patient.
  • The patient is pregnant, parturient, or breastfeeding.
  • The patient has a contraindication (or incompatible drug combination) to drug thromboprophylaxis applied according to good clinical practice and recommendations of learned societies
  • Long-term anticoagulant therapy for personal thrombotic history.
  • Known hemorrhagic disease.
  • Haemorrhagic risk perceived during the consultation of preoperative anesthesia, leading to modify / develop the usual thromboprophylaxis.
  • Chronic liver disease.
  • Chronic renal failure with calculated clearance \<30 ml / min.
  • Extreme body mass index: \<18 kg.m-2 or\> 40 kg.m-2
  • total hip prosthesis or total knee prosthesis in the immediate aftermath of a bone fracture.
  • total hip prosthesis resumption.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nimes University Hospital

Nîmes, 30029, France

Location

Related Publications (1)

  • Chea M, Nouvellon E, Alonso S, Marchand P, Coulomb R, Kouyoumdjian P, Perin M, Laurent J, Mura T, Perez-Martin A, Bouvier S, Gris JC. Automated thrombin generation assay in patients entering hospital for total hip or knee arthroplasty: A prospective study. Thromb Res. 2026 Feb;258:109591. doi: 10.1016/j.thromres.2026.109591. Epub 2026 Jan 19. No abstract available.

    PMID: 41570657RESULT

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Eva Cochery-Nouvellon, Dr

    Centre Hospitalier Universitaire de Nīmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 16, 2018

Study Start

February 21, 2019

Primary Completion

February 20, 2023

Study Completion

October 17, 2023

Last Updated

February 11, 2026

Record last verified: 2023-11

Locations

FR(1)