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Role of Topical Tranexamic Acid in Total Hip Arthroplasty (TXA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01866943
Recruitment Status : Terminated
First Posted : June 3, 2013
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Jose Rodriguez, MD, Northwell Health

Brief Summary:
Total hip arthroplasty (THA) is a procedure associated with perioperative blood loss, requiring blood transfusions in some patients. The major cause of this blood loss is due to surgical trauma that induces the clotting cascade and fibrinolysis. Several previous studies and meta-analyses have shown that tranexamic acid is an effective antifibrinolytic agent that reduces blood loss in a variety of situations. Tranexamic acid given in an intravenous form has been extensively studied and shown to be efficacious in cardiothoracic, spine surgical procedures as well as total knee arthroplasty (TKA) and THA. Similarly, topical tranexamic acid has been associated with decreased blood loss in cardiac surgeries as well. Recently, results from a prospective randomized study on the topical use of tranexamic acid in total knee arthroplasty found it to be effective for reducing postoperative blood loss. Taking all of the above into consideration we have proposed a study to evaluate effects of topical application of tranexamic acid on postoperative blood loss and blood transfusion on patients undergoing total hip arthroplasty. The aim of this study is to evaluate the efficacy of the topical application of tranexamic acid on blood loss in patients undergoing a primary unilateral total hip arthroplasty.

Condition or disease Intervention/treatment Phase
Post Operative Blood Loss Drug: Tranexamic Acid Drug: Normal Saline Solution Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Role of Topical Tranexamic Acid in Total Hip Arthroplasty
Study Start Date : November 2011
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Placebo Comparator: Group 1
Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.
Drug: Normal Saline Solution
Experimental: Group 2
Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline plus 1.5 g (100 mg/mL)Tranexamic Acid is applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.
Drug: Tranexamic Acid
Tranexamic Acid 1.5 g (100 mg/mL)in 100cc normal saline is applied topically to the wound for 5 minutes time then suctioned and the skin closed. The control group receives just normal saline and no drug.




Primary Outcome Measures :
  1. Estimated Blood Loss [ Time Frame: Pre Op, Post Op Day 2 ]
    Estimated Blood Loss defined as Pre Op Hgb mins the Post Op Day two Hgb.


Secondary Outcome Measures :
  1. Mid Thigh Circumference [ Time Frame: Pre Op ]
    Measurement of the thigh at the half way point between the prominence of the greater trochanter and the lateral epicondyle of the femur. No data recorded at 2 weeks or 6 weeks for this study population.

  2. Harris Hip Scores [ Time Frame: Preoperative ]
    Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.

  3. Harris Hip Scores [ Time Frame: 2 week ]
    Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.

  4. Harris Hip Scores [ Time Frame: 6 week ]
    Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-80 years of age.
  • Male or female.
  • Degenerative joint disease of hip joint.
  • Primary uncemented total hip arthroplasty.
  • Willingness to participate in the study, follow up at regular intervals

Exclusion Criteria:

  • Known allergy to tranexamic acid
  • History of any acquired disturbances of color vision
  • Preoperative anemia on basis of pre-operative lab work up (a hemoglobin value of <11 g/dL in females and <12 g/dL in males)
  • History of previous myocardial infarction
  • History of arterial or venous thromboembolic disease
  • History of fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy in the past and/or as identified by a preoperative platelet count of <150,000/mm3, an international normalized ratio of >1.5, or a prolonged partial thromboplastin time
  • Pregnancy (h/o any missed menstrual periods in a women of reproductive age group)
  • Breastfeeding
  • Refusal of blood products
  • Preoperative use of anticoagulant therapy within five days before surgery
  • Medical issues that may pose complications for surgery and would disqualify patient for surgery regardless of clinical trial (e.g. renal and hepatic failure)
  • Major comorbidities (e.g. severe ischemic heart disease )
  • Severe pulmonary disease
  • Preoperative blood donation
  • Participation in another clinical trial involving pharmaceutical drugs

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): NCT01866943


Locations
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United States, New York
North Shore Long Island Jewish Lenox Hill Hospital
New York, New York, United States, 10075
Sponsors and Collaborators
Northwell Health
Publications:

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Responsible Party: Jose Rodriguez, MD, Chieff Of Adult Reconstruction, Department of Orthopedics, Northwell Health
ClinicalTrials.gov Identifier: NCT01866943    
Other Study ID Numbers: 11-253
First Posted: June 3, 2013    Key Record Dates
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018
Last Verified: February 2018
Keywords provided by Jose Rodriguez, MD, Northwell Health:
Blood Loss
Tranexamic Acid
Total Hip Arthroplasty
Post Op
Post Operative
Prevent Post Operative Blood Loss
Additional relevant MeSH terms:
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Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants