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Completed

NCT Number: NCT03634124

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nimes University Hospital

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood test

Biological

Additional blood test of 4,5 ml of venous blood

Doppler Ultrasound

Other

Vascular ultrasonic vascular exploration of the lower limbs

Primary outcomes

  1. 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

    Time frame: Day 0

    Numerical value

  2. Occurrence of Symptomatic pulmonary embolism

    Time frame: Day 7 (± 2)

    yes/non

  3. Occurrence of Symptomatic deep vein thrombosis somewhere in the body

    Time frame: Day 7 (± 2)

    Yes/no

  4. Occurrence of Symptomatic deep vein thrombosis in legs

    Time frame: Day 7 (± 2)

    Yes/non

Secondary outcomes

  1. Occurrence of proximal Symptomatic deep vein thrombosis in legs

    Time frame: Day 7 (± 2)

    Yes/no

  2. Occurrence of distal Symptomatic deep vein thrombosis in legs

    Time frame: Day 7 (± 2)

    Yes/no

  3. Occurrence of muscular Symptomatic deep vein thrombosis in legs

    Time frame: Day 7 (± 2)

    Yes/no

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

    Time frame: Day 7 (± 2)

    Yes/no

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

    Time frame: Day 7 (± 2)

    Yes/no

  6. Occurrence of distal asymptomatic deep vein thrombosis in legs by doppler ultrasound

    Time frame: Day 7 (± 2)

    Yes/no

  7. Occurrence of muscular asymptomatic deep vein thrombosis in legs by doppler ultrasound

    Time frame: Day 7 (± 2)

    Yes/no

  8. Occurrence of any kind of asymptomatic deep vein thrombosis except muscular in legs by doppler ultrasound

    Time frame: Day 7 (± 2)

    Yes/no

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: GT-PT

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 16, 2018
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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