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

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ClinicalTrials.gov Identifier: NCT03634124
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Total Hip Prosthesis Knee Prosthesis Biological: Blood test Other: Doppler ultrasound Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 314 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Generation of Thrombin and Prediction of Deep Vein Thrombosis Post Prosthetic Orthopedic Surgery of the Lower Limbs
Actual Study Start Date : February 21, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: interventional group Biological: Blood test
Additional blood test of 4,5 ml of venous blood

Other: Doppler ultrasound
Vascular ultrasonic vascular exploration of the lower limbs




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03634124


Contacts
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Contact: Eva Cochery-Nouvellon, Dr 04.66.68.32.11 eva.nouvellon@chu-nimes.fr

Locations
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France
Nimes University Hospital Recruiting
Nîmes, France, 30029
Contact: Anissa Megzari    +33 (0)4.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Eva COCHERY-NOUVELLON, Dr         
Sub-Investigator: Christophe BOISSON, Dr         
Sub-Investigator: Philippe CUVILLON, Pr         
Sub-Investigator: Jacques RIPART, Pr         
Sub-Investigator: Pascal KOUYOUMDJIAN, Pr         
Sub-Investigator: Antonia Perez-Martin, Pr         
Sub-Investigator: Jean-Christophe Gris, Pr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Eva Cochery-Nouvellon, Dr Nimes University Hospital
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03634124    
Other Study ID Numbers: NIMAO/2017-01/ECN-01
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases