Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement

Primary Osteoarthritis of Knee Nos Clinical Trial

Official title:

Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement; A Prospective Triple-blinded Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850394
• Other study ID #: ID 01-53-06
• Status: Completed
• Phase: N/A
• First received: May 2, 2013
• Last updated: October 24, 2013
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: October 2013
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine 1) the effective dosage of intra-articular tranexamic acid injection for controlling blood loss and blood transfusion requirement in conventional total knee replacement, and 2) whether the blood loss reduction effect depended on the dose of tranexamic acid used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: January 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• patients diagnosed as primary knee osteoarthritis and underwent unilateral primary cemented conventional total knee replacement

• no risk of abnormal bleeding tendency or bleeding disorder (normal coagulogram, serum creatinine < 2.0 mg/dL, stop nonsteroidal anti-inflammatory drugs and antiplatelet drugs more than 7 days

• no contra-indication for tranexamic acid use (no active intravascular clotting process, no acquired defective colour vision, no subarachnoid hemorrhage, no hypersensitivity to TXA, and no any of history of serious adverse effects, thrombotic disorder and hematuria)

Exclusion Criteria:

• incomplete data collection, for example, malfunctioned drain or accidental drain removal.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Primary Osteoarthritis of Knee Nos

Intervention

Drug:
• Tranexamic Acid
Inject tranexamic acid solution intra-articularly after fascia closure
• Physiologic saline
Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Locations

Country	Name	City	State
Thailand	Ramathibodi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (6)

Ishida K, Tsumura N, Kitagawa A, Hamamura S, Fukuda K, Dogaki Y, Kubo S, Matsumoto T, Matsushita T, Chin T, Iguchi T, Kurosaka M, Kuroda R. Intra-articular injection of tranexamic acid reduces not only blood loss but also knee joint swelling after total knee arthroplasty. Int Orthop. 2011 Nov;35(11):1639-45. doi: 10.1007/s00264-010-1205-3. Epub 2011 Jan 21. — View Citation

Maniar RN, Kumar G, Singhi T, Nayak RM, Maniar PR. Most effective regimen of tranexamic acid in knee arthroplasty: a prospective randomized controlled study in 240 patients. Clin Orthop Relat Res. 2012 Sep;470(9):2605-12. doi: 10.1007/s11999-012-2310-y. Epub 2012 Mar 15. — View Citation

Roy SP, Tanki UF, Dutta A, Jain SK, Nagi ON. Efficacy of intra-articular tranexamic acid in blood loss reduction following primary unilateral total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2494-501. doi: 10.1007/s00167-012-1942-5. Epub 2012 Mar 15. — View Citation

Sa-Ngasoongsong P, Channoom T, Kawinwonggowit V, Woratanarat P, Chanplakorn P, Wibulpolprasert B, Wongsak S, Udomsubpayakul U, Wechmongkolgorn S, Lekpittaya N. Postoperative blood loss reduction in computer-assisted surgery total knee replacement by low dose intra-articular tranexamic acid injection together with 2-hour clamp drain: a prospective triple-blinded randomized controlled trial. Orthop Rev (Pavia). 2011;3(2):e12. doi: 10.4081/or.2011.e12. Epub 2011 Jun 29. — View Citation

Seo JG, Moon YW, Park SH, Kim SM, Ko KR. The comparative efficacies of intra-articular and IV tranexamic acid for reducing blood loss during total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2013 Aug;21(8):1869-74. doi: 10.1007/s00167-012-2079-2. Epub 2012 Jun 24. Erratum in: Knee Surg Sports Traumatol Arthrosc. 2013 Aug;21(8):1875. — View Citation

Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative Blood Loss	Drainage blood loss measured by accumulating total drainage volume postoperatively; Calculated total blood loss measured by using specific formula and difference between hematocrit preoperatively and the fourth postoperative day	5 days after surgery	No
Primary	Total Hemoglobin Loss	Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day	5 days after surgery	No
Secondary	Knee Function Scores	Knee function score was measured with 2 methods, and were evaluated preoperatively and then postoperatively at 3-month, 6-month, and 1-year period.; Knee Society Knee Score using for rating knee function measurement and subdivided into two parts; knee score and function score 1.1. Knee score : calculated from pain, presence of deformity, total range of flexion, alignment, and stability. Total score is 100 (0-100), more score means better.; 1.2. Function score : calculated from patient's ability to walk and climb stairs. The score ranges from 0-100, more score means better.; Western Ontario and McMaster Universities Arthritis Index or WOMAC score : a widely used, standardized questionnaires for evaluating the condition of patients with knee osteoarthritis, including pain (score = 0-20), stiffness (0-8), and functional limitation (0-68). Total score ranges from 0-68, lower score means better.	1 year after surgery	No
Secondary	Number of Patients Required Blood Transfusion		postoperative period (5 days after surgery)	No
Secondary	Number of Patients Having Postoperative Complications	Postoperative complications were measured as an incidence of the following complications; wound hematoma; surgical site infection; systemic infection; deep vein thrombosis; pulmonary embolism; knee stiffness requiring manipulation; medical complication such as myocardial infarction, congestive hear failure	postoperative 1-year period	No