Tranexamic Acid and Drain Use in Knee Arthroplasty

NCT07174895 | Completed

• 2 other identifiers: T.A in Knee ArthroplastyNW-Syria-TKA-Study-01
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized clinical study is designed to evaluate the effects of intra-articular tranexamic acid (TNA), with or without suction drainage, on perioperative blood management in patients undergoing total knee arthroplasty (TKA) for degenerative arthritis. A total of 192 patients will be randomly assigned to three groups: Group 1 will receive TNA with suction drainage, Group 2 will receive TNA only, and Group 3 will receive suction drainage only. The primary outcomes will be total blood loss and transfusion requirements. Secondary outcomes will include hidden blood loss, drainage volume, postoperative limb swelling, wound-related complications, and knee range of motion. The study will help clarify whether suction drainage is necessary when intra-articular TNA is used during TKA.

Conditions

Osteoarthritis, Knee

Keywords

Arthroplasty, Replacement, Knee Tranexamic Acid Blood Loss, Surgical Drainage Perioperative Care Hemostasis, Surgical Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Total Blood Loss

  Total blood loss calculated using changes in hemoglobin concentration and the Good et al. formula.

  Within 72 hours after surgery

Secondary Outcomes (7)

• Hidden Blood Loss

  Within 72 hours after surgery

• Drainage Volume

  24 hours postoperatively

• Number of Blood Transfusions

  During hospital stay (up to 7 days postoperatively)

• Postoperative Limb Swelling

  1, 2, 4, and 6 weeks postoperatively

• Wound-related Complications

  Within 6 weeks after surgery

Study Arms (3)

Tranexamic Acid with Suction Drainage

EXPERIMENTAL

Patients undergoing total knee arthroplasty received intra-articular injection of 3 g tranexamic acid diluted in 100 mL normal saline after wound closure. A closed suction drain was inserted intra-articularly and subcutaneously, activated two hours postoperatively.

Drug: Intra-articular Tranexamic Acid + Suction Drainage

Tranexamic Acid without Drainage

EXPERIMENTAL

Patients undergoing total knee arthroplasty received intra-articular injection of 3 g tranexamic acid diluted in 100 mL normal saline after wound closure. No suction drain was used in this group.

Drug: Intra-articular Tranexamic Acid

Suction Drainage without Tranexamic Acid

ACTIVE COMPARATOR

Patients undergoing total knee arthroplasty had a closed suction drain inserted intra-articularly and subcutaneously, activated two hours postoperatively. No tranexamic acid was administered in this group.

Device: Suction Drainage Only

Interventions

Intra-articular Tranexamic Acid + Suction Drainage DRUG

Patients received intra-articular injection of 3 g tranexamic acid in 100 mL normal saline after wound closure, along with a closed suction drain inserted intra-articularly and subcutaneously, activated two hours postoperatively.

Tranexamic Acid with Suction Drainage

Intra-articular Tranexamic Acid DRUG

Patients received intra-articular injection of 3 g tranexamic acid in 100 mL normal saline after wound closure. No suction drain was used.

Tranexamic Acid without Drainage

Suction Drainage Only DEVICE

Patients had a closed suction drain inserted intra-articularly and subcutaneously, activated two hours postoperatively. No tranexamic acid was administered.

Suction Drainage without Tranexamic Acid

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with degenerative knee arthritis
• Scheduled for unilateral total knee arthroplasty

You may not qualify if:

• Rheumatoid arthritis
• Cardiovascular diseases (e.g., angina, myocardial infarction, arrhythmia, cerebrovascular events)
• Coagulation disorders or thromboembolic disorders
• Severe infections
• Other serious health issues

Sponsors & Collaborators

• Idlib University: lead

Study Sites (1)

Faculity of Medicine

Idlib, Syria

Location

Related Publications (10)

• Hishimura R, Onodera T, Ohkoshi Y, Okada K, Matsuoka M, Matsubara S, Iwasaki K, Kondo E, Iwasaki N. The effect of local injection of tranexamic acid into peri-articular tissue versus drain clamping in total knee arthroplasty: a randomized controlled trial. BMC Musculoskelet Disord. 2022 Feb 2;23(1):111. doi: 10.1186/s12891-022-05058-6.

  PMID: 35109837 BACKGROUND

• Kim MK, Ko SH, Nam YC, Jeon YS, Kwon DG, Ryu DJ. Optimal Release Timing of Drain Clamping to Reduce Postoperative Bleeding after Total Knee Arthroplasty with Intraarticular Injection of Tranexamic Acid. Medicina (Kaunas). 2022 Sep 5;58(9):1226. doi: 10.3390/medicina58091226.

  PMID: 36143903 BACKGROUND

• Liu CH, Chang CH, Chang YH, Shih HN, Hu CC. Topical Fibrin Sealant (Tisseel@) Does Not Provide a Synergic Blood-Conservation Effect with Tranexamic Acid in Total Knee Arthroplasty-A Prospective Randomized Controlled Trial. Medicina (Kaunas). 2023 Nov 26;59(12):2078. doi: 10.3390/medicina59122078.

  PMID: 38138181 BACKGROUND

• Zhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of hypotensive anesthesia and regional anesthesia on intraoperative blood loss in total knee arthroplasty. World J Emerg Surg. 2024;19(1):33. doi:10.1186/s13017-024-00554-7

  BACKGROUND

• Chaiyakit P, Kabkaew P, Hongku N, Wattanapreechanon P. Comparison of total blood loss between limited tourniquet use and conventional tourniquet use in total knee arthroplasty: a randomized controlled trial. BMC Musculoskelet Disord. 2024 Nov 15;25(1):918. doi: 10.1186/s12891-024-08058-w.

  PMID: 39548417 BACKGROUND

• Zhou C, Gao X, Han H, Wang L, Jiang H. The efficacy and safety of tranexamic acid in primary total knee arthroplasty: a systematic review and meta-analysis. J Orthop Surg Res. 2024;19(1):37. doi:10.1177/15563316231208716.

  BACKGROUND

• Liu Y, Ai J, Teng X, Huang Z, Wu H, Zhang Z, Wang W, Liu C, Zhang H. Risk factor analysis and establishment of a nomogram model to predict blood loss during total knee arthroplasty. BMC Musculoskelet Disord. 2024 Jun 10;25(1):459. doi: 10.1186/s12891-024-07570-3.

  PMID: 38858713 BACKGROUND

• Gonzalez-Pola R, Tafoya-Olivos RO, Culebras-Almeida LA, Zermeño-Garcia G, Herrera-Lozano A. Minimizing bleeding and transfusion in single-stage bilateral hip and knee arthroplasty: a systematic review of current interventions. Rev Esp Cir Ortop Traumatol (Engl Ed). 2025;69(2):e58. doi:10.1016/j.recot.2025.02.002.

  BACKGROUND

• Ju Y, Liu H, Jiang W, Huang Q, Zhou Z, Pei F. Perioperative blood loss of sequential administration of hemocoagulase Agkistrodon and Tranexamic acid for primary total knee arthroplasty: a randomized controlled trial. J Orthop Surg Res. 2025 May 13;20(1):457. doi: 10.1186/s13018-025-05867-0.

  PMID: 40355919 BACKGROUND

• Liangliang L, Wei H, Tao Z, Pin P, Lianying H. Efficacy and safety of tranexamic acid in reducing hidden blood loss during unilateral total knee arthroplasty: a retrospective study. Front Med (Lausanne). 2025 Jun 3;12:1552893. doi: 10.3389/fmed.2025.1552893. eCollection 2025.

  PMID: 40529153 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Tranexamic Acid; Suction

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Drainage; Surgical Procedures, Operative

Study Officials

• Mhmoud Adnan Al-Salamah

  Idlib University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable. The study was conducted as an open-label trial with no blinded parties.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Orthopedic Surgery, Idlib University

Model Details: \> This is a prospective randomized clinical trial including 192 patients undergoing total knee arthroplasty. Participants were randomly assigned to one of three groups to assess the effects of intra-articular tranexamic acid and/or suction drainage on total and hidden blood loss, transfusion requirements, postoperative limb swelling, wound-related complications, and knee range of motion.

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 16, 2025
• Study Start: August 6, 2021
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

SY (1)