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Trial record 37 of 57 for:    Recruiting, Not yet recruiting, Available Studies | Arthroscopy

Tourniquet Study: A Clinical Trial Into the Effect of Tourniquet Use on the Coagulation System

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ClinicalTrials.gov Identifier: NCT02567903
Recruitment Status : Recruiting
First Posted : October 5, 2015
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
Leiden University Medical Center
Information provided by (Responsible Party):
Ron Onstenk, Groene Hart Ziekenhuis

Brief Summary:
Knee arthroscopy is the most commonly performed orthopaedic procedure worldwide, with, according to the American Society for Sports Medicine, over 4 million procedures performed each year. The risk of venous thrombosis following this procedure is considerable with rates of symptomatic events varying between 0.9% and 4.6%. It is currently unknown how this high risk comes about considering its short duration and minimal tissue damage caused by the procedure. A factor that may play a role is the use of a tourniquet. A large majority of orthopaedic surgeons prefer to operate within a 'dry field', which is obtained by the use of a tourniquet. Tourniquet applied surgery is not without risks. Although its use during orthopedic surgery is widely accepted and a standard procedure, tourniquet use can lead to loss of muscle functional strength and contractile speed, vessel wall damage and nerve injury, next to the possibly increased risk of venous thrombosis. In the proposed study the investigators will investigate the effect of a tourniquet on local and systemic markers of hypoxia, inflammation, involvement of endothelium, and coagulation activation. A finding of more prominent activation of the coagulation system with tourniquet use than with non-use will create an important opportunity to prevent thromboembolic events in these patients, as it has been shown that knee arthroscopy can be performed adequately without the use of a tourniquet. Furthermore, it will increase the understanding of the pathophysiology of thrombosis.

Condition or disease Intervention/treatment Phase
Venous Thrombosis Device: Thigh Tourniquet Procedure: Knee arthroscopy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Tourniquet Study: Is the High Thrombosis Risk After Knee Arthroscopy Caused by Limb-tourniquet Application? A Randomized Clinical Trial Into the Effect of Tourniquet Use on the Coagulation System
Actual Study Start Date : September 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: No Tourniquet
Knee arthroscopy without the use of a thigh tourniquet.
Procedure: Knee arthroscopy
Knee arthroscopy

Experimental: Tourniquet
Knee arthroscopy with the use of a thigh tourniquet.
Device: Thigh Tourniquet
Knee arthroscopy with the use of a thigh tourniquet that is inflated to 100-150 mmHg above systolic blood pressure.

Procedure: Knee arthroscopy
Knee arthroscopy




Primary Outcome Measures :
  1. Change in parameters that reflect a hypoxic state assessed by pH [ Time Frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery. ]
    Change in pH between timepoints

  2. Change in parameters that reflect a hypoxic state assessed by pO2 [ Time Frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery. ]
    Change in pO2 between timepoints

  3. Change in parameters that reflect a hypoxic state assessed by pCO2 [ Time Frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery. ]
    Change in pCO2 between timepoints

  4. Change in parameters that reflect a hypoxic state assessed by Lactate [ Time Frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery. ]
    Change in Lactate between timepoints

  5. Change in parameters that reflect an inflammatory reaction assessed by WBCC [ Time Frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery. ]
    Change in White Blood Cell Count (WBCC) between timepoints

  6. Change in parameters that reflect an inflammatory reaction and/or endothelium involvement assessed by E-selectin [ Time Frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery. ]
    Change in E-selectin between timepoints

  7. Change in parameters that reflect an inflammatory reaction assessed by NETs [ Time Frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery. ]
    Change in Neutrophil Extracellular traps (NETs) between timepoints

  8. Outcome parameters that reflect involvement of the endothelium assessed by vWF [ Time Frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery. ]
    Change in Von Willebrand Factor (vWF) between timepoints

  9. Outcome parameters that reflect involvement of the endothelium assessed by thrombomodulin. [ Time Frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery. ]
    Change in Thrombomodulin between timepoints

  10. Outcome parameters that reflect involvement of the endothelium assessed by f 1+2 [ Time Frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery. ]
    Change in Prothrombin fragments 1+2 (f 1+2) between timepoints

  11. Outcome parameters that reflect a procoagulant state and thrombin formation assessed by D-dimer [ Time Frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery. ]
    Change in D-dimer between timepoints

  12. Outcome parameters that reflect a procoagulant state and thrombin formation assessed by PAI 1 [ Time Frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery. ]
    Change in Plasmin Activator Inhibitor 1 (PAI 1) between timepoints

  13. Outcome parameters that reflect a procoagulant state and thrombin formation assessed by tPA [ Time Frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery. ]
    Change in Tissue plasminogen activator (tPA) between timepoints

  14. Outcome parameters that reflect a procoagulant state and thrombin formation assessed by factor VIII [ Time Frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery. ]
    Change in Factor VIII between timepoints

  15. Outcome parameters that reflect a procoagulant state and thrombin formation assessed by TAT [ Time Frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery. ]
    Change in Thrombin and Antithrombin complexes (TAT) between timepoints

  16. Outcome parameters that reflect a procoagulant state and thrombin formation assessed by PAP [ Time Frame: Change in parameters between timepoints; Before surgery (blood drawn approximately 1 hour before surgery), directly after surgery (blood drawn within 5 minutes), 1 hour after surgery. ]
    Change in Plasmin and antiplasmin complexes (PAP) between timepoints


Secondary Outcome Measures :
  1. Duration of surgery [ Time Frame: intraoperative, duration in minutes between first incision until closure ]
    The total duration of surgery in minutes

  2. Duration of tourniquet use [ Time Frame: intraoperative, duration in minutes between tourniquet inflation and deflation ]
    The total duration of tourniquet inflation in minutes

  3. Per-operative visibility [ Time Frame: Per-operative ]
    Visibility during surgery, measured on a Visual Analogue Scale scale (0-10)



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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

  • Meniscectomy
  • Diagnostic arthroscopy
  • Removal of corpora libera

Exclusion Criteria

  • Any kind of coagulation disorder
  • pregnant or within 3 months of childbirth
  • Use of hormonal anticonception
  • A history of venous thrombosis
  • Had major surgery in the past two months
  • A history of cast-immobilization of the lower extremity the past two months
  • A neoplasm or inflammatory disease
  • A BMI>30
  • using anticoagulant therapy
  • Any other anaesthesia technique than spinal anaesthesia

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): NCT02567903


Contacts
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Contact: Banne Nemeth, MD +31 71 526 5635 b.nemeth@lumc.nl
Contact: Ron Onstenk, MD ron.onstenk@ghz.nl

Locations
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Netherlands
Groene Hart Ziekenhuis Recruiting
Gouda, Zuid Holland, Netherlands, 2803HH
Principal Investigator: Ron Onstenk, MD         
Sponsors and Collaborators
Groene Hart Ziekenhuis
Leiden University Medical Center
Investigators
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Study Chair: Suzanne C Cannegieter, MD, PhD Leiden University Medical Center

Publications:
American Academy of Orthopaedic Surgeons. Knee Arthroscopy. 2013. http://orthoinfo.aaos.org/topic.cfm?topic=a00299. Accessed April 15, 2014

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Responsible Party: Ron Onstenk, MD, Groene Hart Ziekenhuis
ClinicalTrials.gov Identifier: NCT02567903     History of Changes
Other Study ID Numbers: NL49117.058.14
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases