Topical Tranexamic Acid and Acute Blood Loss in Total Knee Arthroplasty

NCT ID: NCT01370460

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-09-30

Brief Summary

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

Detailed Description

Autologous (donor) blood transfusion is an expensive and common occurrence after total knee replacement. Published data puts this rate between 9 and 40% after primary unilateral total knee arthroplasty. 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 knee replacement, 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 knee arthroplasty. The topical form of the drug has been shown to achieve these hemostatic effects without increasing the risk of blood clots after surgery. Furthermore, the one aforementioned randomized clinical trial used a variety of postoperative deep vein thrombosis prophylaxis after surgery and introduced a potential confounding variable. 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.

Conditions

Acute Blood Loss Anemia; Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tranexamic Acid

Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

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

Placebo

100mL 0.9% NS, applied topically

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

100mL 0.9% sterile saline

Interventions

Tranexamic Acid

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

Intervention Type: DRUG

Placebo

100mL 0.9% sterile saline

Intervention Type: DRUG

Other Intervention Names

Cyklokapron

Eligibility Criteria

Inclusion Criteria

• All adult patients over age eighteen
• Primary unilateral total knee 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Laker, M.D.

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

Henry Ford Hospital

Detroit, Michigan, United States

Countries

United States

References

Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.

Reference Type: BACKGROUND

PMID: 21936146 (View on PubMed)

Good L, Peterson E, Lisander B. Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement. Br J Anaesth. 2003 May;90(5):596-9. doi: 10.1093/bja/aeg111.

Reference Type: BACKGROUND

PMID: 12697586 (View on PubMed)

Other Identifiers

IRB 6669

Identifier Type: -

Identifier Source: org_study_id