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NCT Number: NCT07174895

Tranexamic Acid and Drain Use in Knee Arthroplasty

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculity of Medicine

Idlib, Syria

About this study

Total knee arthroplasty (TKA) is commonly associated with significant perioperative blood loss, which may increase transfusion requirements and associated risks such as immunologic reactions, infection, and delayed recovery. Tranexamic acid (TNA) is an antifibrinolytic agent that inhibits fibrinolysis by blocking the activation of plasminogen. Suction drainage is frequently used to prevent hematoma formation, but its benefit in reducing transfusion needs remains controversial.

This single-center, prospective randomized study will enroll 192 patients undergoing unilateral TKA for degenerative arthritis. Participants will be assigned to three groups: (1) TNA with suction drainage, (2) TNA only, and (3) suction drainage only. TNA will be administered intra-articularly at a dose of 3 g in 100 mL normal saline after wound closure. When applied, suction drains will be activated two hours postoperatively.

The primary outcomes will be total blood loss and transfusion requirement. The secondary outcomes will include hidden blood loss, drainage volume, postoperative limb swelling, wound-related complications, and knee range of motion at two months. Statistical analysis will be conducted using ANOVA, repeated-measures t-tests, and chi-square tests, with significance set at p ≤ 0.05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

Suction Drainage Only

Device

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

Primary outcomes

  1. Total Blood Loss

    Time frame: Within 72 hours after surgery

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

Secondary outcomes

  1. Hidden Blood Loss

    Time frame: Within 72 hours after surgery

    Hidden blood loss calculated as total blood loss minus drainage volume.

  2. Drainage Volume

    Time frame: 24 hours postoperatively

    Total drainage collected through suction drains when applicable.

  3. Number of Blood Transfusions

    Time frame: During hospital stay (up to 7 days postoperatively)

    Number of patients receiving blood transfusions based on NIH Consensus criteria (Hb < 8.0 g/dL, or <10.0 g/dL with symptoms).

  4. Postoperative Limb Swelling

    Time frame: 1, 2, 4, and 6 weeks postoperatively

    Change in limb circumference at thigh, knee, and calf compared with preoperative baseline.

  5. Wound-related Complications

    Time frame: Within 6 weeks after surgery

    Incidence of wound-related issues, including infection, hematoma, erythema, or superficial wound complications.

  6. Thromboembolic Events (DVT/PE)

    Time frame: Within 6 weeks after surgery

    Incidence of deep vein thrombosis (DVT) confirmed with Doppler ultrasonography and pulmonary embolism (PE) if suspected clinically.

  7. Postoperative Knee Range of Motion

    Time frame: 2 months postoperatively

    Range of motion measured with a goniometer (flexion and extension).

Sponsors and collaborators

Lead sponsor

Idlib University

Other

Registry information

Official study title

Efficacy of Tranexamic Acid With/Without Drain in Knee Arthroplasty: A Study From Northwest Syria

Acronym: TNAKnee

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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