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Generation of Thrombin and Prediction of Deep Vein Thrombosis Post Prosthetic Orthopedic Surgery of the Lower Limbs (GT-PT)

Primary Purpose

Deep Vein Thrombosis, Total Hip Prosthesis, Knee Prosthesis

Status
Active
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Blood test
Doppler ultrasound
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Deep Vein Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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.
  • Installation of more than one joint prosthesis.
  • Surgery in the previous 3 months.
  • Infective push in the previous 3 months.
  • Indication of haemostatic treatment for abnormal haemorrhagic risk.
  • Severe impairment of renal function with a calculated clearance <30 ml / min.
  • Contraindication (allergic, metabolic, other ...) to usual drug thromboprophylaxis.
  • Condition requiring dosage adjustment of drug thromboprophylaxis.
  • Indication to put in place intermittent pneumatic compression for perioperative thromboprophylaxis.

Sites / Locations

  • Nimes University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

interventional group

Arm Description

Outcomes

Primary Outcome Measures

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
Occurrence of Symptomatic pulmonary embolism
yes/non
Occurrence of Symptomatic deep vein thrombosis somewhere in the body
Yes/no
Occurrence of Symptomatic deep vein thrombosis in legs
Yes/non

Secondary Outcome Measures

Occurrence of proximal Symptomatic deep vein thrombosis in legs
Yes/no
Occurrence of distal Symptomatic deep vein thrombosis in legs
Yes/no
Occurrence of muscular Symptomatic deep vein thrombosis in legs
Yes/no
Occurrence of any kind of Symptomatic deep vein thrombosis in legs except muscular
Yes/no
Occurrence of proximal asymptomatic deep vein thrombosis in legs by doppler ultrasound
Yes/no
Occurrence of distal asymptomatic deep vein thrombosis in legs by doppler ultrasound
Yes/no
Occurrence of muscular asymptomatic deep vein thrombosis in legs by doppler ultrasound
Yes/no
Occurrence of any kind of asymptomatic deep vein thrombosis except muscular in legs by doppler ultrasound
Yes/no

Full Information

First Posted
August 7, 2018
Last Updated
June 5, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT03634124
Brief Title
Generation of Thrombin and Prediction of Deep Vein Thrombosis Post Prosthetic Orthopedic Surgery of the Lower Limbs
Acronym
GT-PT
Official Title
Generation of Thrombin and Prediction of Deep Vein Thrombosis Post Prosthetic Orthopedic Surgery of the Lower Limbs
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
February 20, 2023 (Actual)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Total Hip Prosthesis, Knee Prosthesis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
314 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
interventional group
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Blood test
Intervention Description
Additional blood test of 4,5 ml of venous blood
Intervention Type
Other
Intervention Name(s)
Doppler ultrasound
Intervention Description
Vascular ultrasonic vascular exploration of the lower limbs
Primary Outcome Measure Information:
Title
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
Description
Numerical value
Time Frame
Day 0
Title
Occurrence of Symptomatic pulmonary embolism
Description
yes/non
Time Frame
Day 7 (± 2)
Title
Occurrence of Symptomatic deep vein thrombosis somewhere in the body
Description
Yes/no
Time Frame
Day 7 (± 2)
Title
Occurrence of Symptomatic deep vein thrombosis in legs
Description
Yes/non
Time Frame
Day 7 (± 2)
Secondary Outcome Measure Information:
Title
Occurrence of proximal Symptomatic deep vein thrombosis in legs
Description
Yes/no
Time Frame
Day 7 (± 2)
Title
Occurrence of distal Symptomatic deep vein thrombosis in legs
Description
Yes/no
Time Frame
Day 7 (± 2)
Title
Occurrence of muscular Symptomatic deep vein thrombosis in legs
Description
Yes/no
Time Frame
Day 7 (± 2)
Title
Occurrence of any kind of Symptomatic deep vein thrombosis in legs except muscular
Description
Yes/no
Time Frame
Day 7 (± 2)
Title
Occurrence of proximal asymptomatic deep vein thrombosis in legs by doppler ultrasound
Description
Yes/no
Time Frame
Day 7 (± 2)
Title
Occurrence of distal asymptomatic deep vein thrombosis in legs by doppler ultrasound
Description
Yes/no
Time Frame
Day 7 (± 2)
Title
Occurrence of muscular asymptomatic deep vein thrombosis in legs by doppler ultrasound
Description
Yes/no
Time Frame
Day 7 (± 2)
Title
Occurrence of any kind of asymptomatic deep vein thrombosis except muscular in legs by doppler ultrasound
Description
Yes/no
Time Frame
Day 7 (± 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. 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. Installation of more than one joint prosthesis. Surgery in the previous 3 months. Infective push in the previous 3 months. Indication of haemostatic treatment for abnormal haemorrhagic risk. Severe impairment of renal function with a calculated clearance <30 ml / min. Contraindication (allergic, metabolic, other ...) to usual drug thromboprophylaxis. Condition requiring dosage adjustment of drug thromboprophylaxis. Indication to put in place intermittent pneumatic compression for perioperative thromboprophylaxis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Cochery-Nouvellon, Dr
Organizational Affiliation
Centre Hospitalier Universitaire de Nīmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nimes University Hospital
City
Nîmes
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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Generation of Thrombin and Prediction of Deep Vein Thrombosis Post Prosthetic Orthopedic Surgery of the Lower Limbs

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