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Topical Tranexamic Acid and Acute Blood Loss in Total Hip Arthroplasty

Topical Tranexamic Acid and Acute Blood Loss in Total Hip Arthroplasty

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01683955
Enrollment
139
Registered
2012-09-12
Start date
2013-01-01
Completion date
2013-11-03
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Blood Loss Anemia, Osteoarthritis, Hip

Keywords

Tranexamic Acid, Blood transfusion, Total hip arthroplasty

Brief summary

This study aims to assess postoperative blood loss and transfusion rates in total hip replacement after one-time administration of topical tranexamic acid.

Detailed description

Autologous (donor) blood transfusion is an expensive and common occurrence after total hip replacement. There have been many proposed adjunctive measures to decrease intraoperative and postoperative blood loss during such surgery. Most of these include thrombin inhibition, so-called minimally- invasive techniques or instrumentation, or other adjunctive drugs. Hitherto, tranexamic acid, a specific drug that promotes part of the clotting cascade, has been used extensively in multiple areas of surgery with multiple studies evaluating its efficacy in cardiac surgery, spinal procedures, and as a dental swishing solution after tooth extraction. There have been small studies evaluating intravenous tranexamic acid and its effect on total hip replacements, with some promising results. The topical form of TA has been evaluated in only one prospective, randomized clinical trial with a significant decrease in postoperative blood loss and a trend towards decreased autologous blood transfusion rates. This study proposes to further evaluate tranexamic acid as an inexpensive and viable option for use in total hip arthroplasty. The topical form of the drug has been shown to achieve these hemostatic effects without increasing the risk of blood clots after surgery. A rigorous analysis of the effects of tranexamic acid demand a more standardized approach. Such a regimen is practiced at Henry Ford Hospital as all patients on the Adult Reconstruction service are placed on an identical dose of enoxaparin (a subcutaneous blood thinner) postoperatively for two weeks.

Interventions

DRUGTranexamic acid

Topical tranexamic acid (2g/100mL 0.9% saline)

DRUGPlacebo

100mL 0.9% sterile saline

Sponsors

Henry Ford Health System
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All adult patients over age eighteen * Primary unilateral total hip arthroplasty at Henry Ford Hospital (Detroit, Michigan, United States) and Henry Ford West Bloomfield Hospital (West Bloomfield, Michigan, United States)

Exclusion criteria

* patient history of venous thromboembolic disease or coagulopathy * use of anticoagulant medications within 7 days of surgery * history of arterial embolic disease * history of Class III or IV heart failure * renal failure * intraoperative cardiovascular, pulmonary, orthopaedic, or anesthetic complication (MI, intraoperative fracture, vasopressor support, emergent intubation).

Design outcomes

Primary

MeasureTime frameDescription
postoperative blood lossparticipants will be followed for the duration of hospital stay, an expected average of 3 daysPreoperative and lowest postoperative hemoglobin

Secondary

MeasureTime frameDescription
postoperative transfusion rateparticipants will be followed for the duration of hospital stay, an expected average of 3 daysnumber of units transfused postoperatively

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026