Clinical trial NCT01260818: Topical Application of Tranexamic Acid Reduces Postoperative Blood Loss in Total Hip Arthroplasty
Official title: Prospective Randomized Trial Comparing Topical Tranexamic Acid Plus Standard Of Care Versus Standard Of Care For The Reduction Of Blood Loss Following Primary Total Hip Arthroplasty Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Replacement
Postoperative Hemorrhage
Keywords: Tranexamic Acid
Lead sponsor: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2010-12-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. Most trials in orthopedic surgery have been conducted intravenously in arthroplasty, hip fracture and spine surgeries. This study would aim to see the effect of topical use of tranexamic acid in reduction of blood loss and transfusions for total hip arthroplasty


Eligibility criteria: Inclusion Criteria:

* Patient who are to undergo elective total hip arthroplasty.
* Must be primary arthroplasty.
* Must be single-side arthroplasty.
* Must be older than 18 years.

Exclusion Criteria:

* Cemented arthroplasty.
* Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia .
* Patients with known coagulopathy (APTT or PT outside normal range pre-operatively).
* Patients who have a past medical history of thrombi-embolism at any time.
* Patients with anemia (hemoglobin levels less than 8 mg/dl or hematocrit \<24%).
* Patients with documented DVT or PE at screening or in past three months.
* Patients having known hypersensitivity to tranexamic acid or any other. constituent of the product.
* Patients with any associated major illness (e.g., severe cardiac \[New York Heart Association Class III or IV\] or respiratory disease).
* Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week.
* Jehovah's Witnesses, or any other group of patients with ethical objections to receiving blood products.

Primary outcomes:
measure: Blood loss as calculated from change in haematocrit
timeFrame: 7 days
Secondary outcomes:
measure: Intra-operative blood loss
timeFrame: 1 day
measure: Postoperative blood loss
timeFrame: postoperative 4 hours, 1 day, 2 days, 7days respectively
measure: Hemoglobin levels
timeFrame: postoperative 4 hours, 1 day, 2 days, 7days respectively
measure: drainage volume
timeFrame: postoperative 1 day, 2 days
measure: Proportion of patients receiving transfusions
timeFrame: 7 days
measure: Incidence of deep vein thrombosis postoperatively
timeFrame: 7 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the First Affiliated Hospital of Guangzhou TCM University
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
name: Yong Li
role: PRINCIPAL_INVESTIGATOR
References: