Completed

GT-PTThrombin Generation and Deep Vein Thrombosis Risk After Lower Limb Orthopedic Surgery

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Study Aim

This phase 3 study aims to evaluate the ratio of thrombin generation test values and observe the occurrence of symptomatic deep vein thrombosis in legs, elsewhere in the body, and pulmonary embolism after lower limb orthopedic surgery.

What is being tested

Blood test

+ Doppler ultrasound

BiologicalOther
Who is being recruted

Cardiovascular Diseases+2

+ Thrombosis

+ Vascular Diseases

Over 18 Years
+28 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Phase 3
Interventional
Study Start: February 2019
See protocol details

Summary

Principal SponsorCentre Hospitalier Universitaire de Nīmes
Last updated: February 12, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 21, 2019

Actual date on which the first participant was enrolled.

This clinical trial focuses on understanding the risk of developing deep vein thrombosis (DVT), a condition where blood clots form in the deep veins of the body, usually in the legs. This study is specifically for individuals who have undergone prosthetic orthopedic surgery of the lower limbs, such as total hip or knee replacement. The study aims to predict the risk of early DVT after surgery by comparing the results of two thrombin generation tests performed before the surgery. Thrombin is a key protein involved in blood clotting. The hope is that the findings of this study could help improve care for patients undergoing such surgeries by providing a way to predict and potentially prevent DVT. In this study, participants will undergo two thrombin generation tests before their surgery. One test will be performed without soluble thrombomodulin, a protein that helps regulate blood clotting, and the other test will be performed with it. The ratio between the values of these two tests will be calculated. After surgery, participants will be monitored for symptoms of DVT in the legs, elsewhere in the body, and for symptoms of pulmonary embolism, a condition where a blood clot travels to the lungs. The study measures the occurrence of these conditions as 'yes' or 'no' and also records the numerical value of the test ratio. The potential benefit of participating in this study is gaining a better understanding of one's risk of DVT after surgery.

Official TitleGeneration of Thrombin and Prediction of Deep Vein Thrombosis Post Prosthetic Orthopedic Surgery of the Lower Limbs
NCT03634124
Principal SponsorCentre Hospitalier Universitaire de Nīmes
Last updated: February 12, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

146 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesThrombosisVascular DiseasesEmbolism and ThrombosisVenous Thrombosis

Criteria

4 inclusion criteria required to participate
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

24 exclusion criteria prevent from participating
The patient is pregnant, parturient, or breastfeeding.

The patient is participating in another interventional study.

The patient is in an exclusion period determined by a previous study.

Minor patients, people in emergency situations.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Nimes University Hospital

Nîmes, FranceOpen Nimes University Hospital in Google Maps
CompletedOne Study Center