Role of Topical Tranexamic Acid in Total Hip Arthroplasty
Condition: Post Operative Blood Loss
MeSH terms: Hemorrhage; Postoperative Hemorrhage
Intervention: Tranexamic Acid; Normal Saline Solution
Intervention description: 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.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Blood Loss; Tranexamic Acid; Total Hip Arthroplasty; Post Op; Post Operative; Prevent Post Operative Blood Loss

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.
    

Eligibility 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