GT-PTThrombin Generation and Deep Vein Thrombosis Risk After Lower Limb Orthopedic Surgery
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.
Blood test
+ Doppler ultrasound
Cardiovascular Diseases+2
+ Thrombosis
+ Vascular Diseases
Other Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.146 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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