Clinical trial NCT01866943: Role of Topical Tranexamic Acid in Total Hip Arthroplasty
Official title: Role of Topical Tranexamic Acid in Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Post Operative Blood Loss
Keywords: Blood Loss
Tranexamic Acid
Total Hip Arthroplasty
Post Op
Post Operative
Prevent Post Operative Blood Loss
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2013-06-03
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Estimated Blood Loss
timeFrame: Pre Op, Post Op Day 2
Secondary outcomes:
measure: Mid Thigh Circumference
timeFrame: Pre Op
measure: Harris Hip Scores
timeFrame: Preoperative
measure: Harris Hip Scores
timeFrame: 2 week
measure: Harris Hip Scores
timeFrame: 6 week
Other outcomes:
Locations:
city: New York
country: United States
facility: North Shore Long Island Jewish Lenox Hill Hospital
state: New York
Study officials:
References:
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