Tranexamic Acid and Drain Use in Knee Arthroplasty (TNAKnee)

Idlib University

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Device: Suction Drainage Only; Drug: Intra-articular Tranexamic Acid + Suction Drainage; Drug: Intra-articular Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT07174895

T.A in Knee Arthroplasty

NW-Syria-TKA-Study-01 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 192 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 3 patient groups

Tranexamic Acid with Suction Drainage

Experimental group

Description:

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.

Treatment:

Drug: Intra-articular Tranexamic Acid + Suction Drainage

Tranexamic Acid without Drainage

Experimental group

Description:

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.

Treatment:

Drug: Intra-articular Tranexamic Acid

Suction Drainage without Tranexamic Acid

Active Comparator group

Description:

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.

Treatment:

Device: Suction Drainage Only