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Trial record 73 of 418 for:    TRANEXAMIC ACID

Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical

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ClinicalTrials.gov Identifier: NCT01940523
Recruitment Status : Completed
First Posted : September 12, 2013
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Brief Summary:
The purpose of this study is to determine whether topical or intravenous administration of tranexamic acid during unilateral total knee replacement is more effective at reducing bleeding in the first 24 hours following surgery. Tranexamic acid is a synthetic drug that has been shown to reduce blood drain output and the need for blood transfusions in both its topical and intravenous forms and is commonly used in orthopedic surgery. We hypothesize that IV and topical administration of tranexamic acid will be equally good at reducing the loss of blood and the need for transfusion immediately following total knee replacement.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Topical Tranexamic Acid Drug: Intravenous Tranexamic Acid Phase 4

Detailed Description:

This randomized controlled trial compares the blood loss of patients undergoing unilateral total knee replacements who randomly receive either the topical or the intravenous form of tranexmamic acid during surgery. Patients in the intravenous arm of the study will receive 1 gram of tranexamic acid in 10 milliliters of solution prior to inflation of the tourniquet and 1 gram of tranexamic acid in 10 milliliters of solution during closure. For patients in the topical arm of the study, prior to the release of the tourniquet they will receive 3 grams of tranexamic acid in 75ccs of solution directly on the site of the incision.

The primary result measurement will be blood drain output from the knee at 24 hours after surgery.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical
Actual Study Start Date : May 2013
Actual Primary Completion Date : December 28, 2015
Actual Study Completion Date : May 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Topical Tranexamic Acid
3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. After that, the tourniquet will be released and the rest of the surgery will proceed according to the standard of care.
Drug: Topical Tranexamic Acid
3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. After that, the tourniquet will be released and the rest of the surgery will proceed according to the standard of care.

Active Comparator: Intravenous Tranexamic Acid
1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
Drug: Intravenous Tranexamic Acid
1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.




Primary Outcome Measures :
  1. Total Blood Loss [ Time Frame: during surgery ]
    The amount of blood lost during surgery is the primary outcome measure. Blood loss is determineusing an equation that calculates the patient's blood volume based on their height and weight, then multiplies the patient's blood volume by the change in their hematocrit after surgery compared to before surgery.


Secondary Outcome Measures :
  1. Drain Output [ Time Frame: from end of surgery to 24 hours postoperatively ]
    The amount of blood collected by a drain attached to the knee is measured 24 hours after surgery.

  2. Units of Transfusion [ Time Frame: over course of hospital stay (averaging three days) ]
    The number of units of perioperative blood transfusions, both intraoperative and postoperative, over the course of the patient's hospital stay.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary total knee replacmeent
  • Osteoarthritis
  • Unilateral

Exclusion Criteria:

  • Revision surgery
  • Donated preoperative autologous blood
  • On chronic anticoagulation medication such as Coumadin, Xarelto, Plavix, or Aspirin (other than 81mg)
  • Preoperative hepatic or renal dysfunction
  • Diagnosis of inflammatory disease
  • Diagnosis of inflammatory arthritis
  • Pregnant
  • Breastfeeding
  • Preoperative hemoglobin <10g/dL
  • International Normalized Ratio>1.4
  • Abnormal Partial Thromboplastin Time
  • Preoperative platelet count of <150,000mm^3
  • Creatinine > 1.4

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): NCT01940523


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Mayo Clinic
Investigators
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Principal Investigator: David Mayman, MD Hospital for Special Surgery, New York

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01940523     History of Changes
Obsolete Identifiers: NCT02123095
Other Study ID Numbers: 12166
First Posted: September 12, 2013    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Keywords provided by Hospital for Special Surgery, New York:
total knee arthroplasty
total knee replacement
tranexamic acid
osteoarthritis
degenerative joint disease
Additional relevant MeSH terms:
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Tranexamic Acid
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pharmaceutical Solutions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants