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Trial record 63 of 419 for:    TRANEXAMIC ACID

The Effect of Tranexamic Acid on Blood Coagulation in Total Hip Arthroplasty Surgery

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ClinicalTrials.gov Identifier: NCT03897621
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Uzung Yoon, Thomas Jefferson University

Brief Summary:
Total hip arthroplasty (THA) is associated with blood loss ranging from 300 to 2000 mL. Tranexamic acid (TXA) is frequently administered prophylactically during this procedure to reduce blood loss by inhibiting fibrinolysis or by stopping naturally occurring clot resolution. TXA is employed currently based on a surgeon's preference. The objective of this study is to quantitate the degree of fibrinolysis using rotational thromboelastometry (ROTEM) and investigate the role of TXA prophylaxis on blood loss in patients undergoing THA in a double-blind fashion. Our hypothesis is that fibrinolysis is minimal at most and TXA prophylaxis is not necessary during THA. All patients, whether they receive TXA or normal saline, will not be at risk, as at this time no data exists to determine which approach is safer or more effective. This is the first study to compare TXA vs. placebo in a double-blinded, randomized controlled trial.

Condition or disease Intervention/treatment Phase
Coagulation; Intravascular Rotational Thromboelastometry Fibrinolysis; Hemorrhage Tranexamic Acid Total Hip Arthroplasty Drug: Tranexamic Acid Drug: Placebo Not Applicable

Detailed Description:
Total hip arthroplasty (THA) is associated with moderate blood loss ranging from 300 to 2000 mL. Tranexamic acid (TXA) is frequently administered prophylactically during this procedure to reduce blood loss by inhibiting fibrinolysis. Most clinical studies reported potential benefit of the treatment demonstrated by less estimated blood loss (EBL), reduced hemoglobin/hematocrit (HH) change, and reduced transfused packed red blood cells (PRBC). However, bleeding complication may be affected more significantly by the degree of surgical trauma and comorbidity of patients than coagulation abnormality. Further, the frequency and severity of fibrinolysis during these procedures have not been well studied. Additionally, TXA administration may increase the tendency of postoperative venous thrombosis by inhibiting fibrinolysis in already prothrombotic patients. The objective of this study is to quantitate the degree of fibrinolysis using rotational thromboelastometry (ROTEM) and investigate the role of TXA prophylaxis on clinical outcome in patients undergoing THA in a double-blind fashion. Our hypothesis is that fibrinolysis is minimal at most and TXA prophylaxis is not necessary during primary THA.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blinded randomized controlled trial
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Effect of Tranexamic Acid on Blood Coagulation in Total Hip Arthroplasty Surgery Based on Rotational Thromboelastometry (ROTEM®).
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : August 20, 2020
Estimated Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: tranexamic acid
Patients undergoing unilateral, primary, total hip arthroplasty with English as their native language
Drug: Tranexamic Acid
tranexamic acid will be administered intravenously after induction of anesthesia (a bolus of 10 mg/kg or maximal dose of 1g).

Placebo Comparator: Normal saline
Patients undergoing unilateral, primary, total hip arthroplasty with English as their native language
Drug: Placebo
Patients in the placebo group will receive normal saline (a bolus of sodium chloride 0.9%, 0.1 mL/kg or maximal dose of 10 mL).




Primary Outcome Measures :
  1. Fibrinolysis [ Time Frame: after induction of anesthesia (baseline), ]
    Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) >15%

  2. Fibrinolysis [ Time Frame: 45 min after drug administration, ]
    Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) >15%

  3. Fibrinolysis [ Time Frame: one hour after the end of surgery ]
    Fibrinolysis based on ROTEM parameter, defined as ML (maxium lysis) >15%


Secondary Outcome Measures :
  1. Blood loss [ Time Frame: during surgery (intraoperative) ]
    amount of blood loss in milliliter during surgery

  2. blood transfusion [ Time Frame: Intraoperative and up to 72-hour after surgery ]
    Amount of Packed Red Blood Cells (PRBC) transfused

  3. pre- and postoperative hemoglobin level [ Time Frame: up to 72-hour after surgery ]
    Pre and postoperative hemoglobin level in grams per deciliter

  4. Wound infection [ Time Frame: up to 72-hour after surgery ]
    Incidence of wound infection

  5. Hematoma [ Time Frame: up to72-hour after surgery ]
    Incidence of hematoma

  6. Thrombotic events (PE, DVT). [ Time Frame: up to 72-hour after surgery ]
    Incidence of thrombotic events (pulmonary embolism, deep vein thrombosis)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The study population will include total of 200 adults (age range of 18 - 85 years) who are in the American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3. Inclusion criteria are patients undergoing unilateral, primary, total hip arthroplasty.

Exclusion Criteria:

  • Exclusion criteria include patient's refusal, patients with history of significant coagulopathy or on anticoagulation therapy. Female patients who are pregnant or nursing will be excluded. In addition, patients with anemia (Hb < 8 g/dL) or who received blood transfusion within one week before surgery will be excluded. Patient receiving subcutaneous heparin on the same day prior to surgery will be also excluded.

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): NCT03897621


Contacts
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Contact: Uzung Yoon, M.D. 2159100557 uzung.yoon@jefferson.edu

Locations
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United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Uzung Yoon, M.D    215-910-0557    uzung.yoon@gmail.com   
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Uzung Yoon Thomas Jefferson University

Publications of Results:

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Responsible Party: Uzung Yoon, Clinical Instructor, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03897621     History of Changes
Other Study ID Numbers: 18D.581
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Uzung Yoon, Thomas Jefferson University:
tranexamic acid
Rotational thromboelastometry
Fibrinolysis
viscoelastic essay
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants