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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
192
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.
Patients received intra-articular injection of 3 g tranexamic acid in 100 mL normal saline after wound closure. No suction drain was used.
Patients had a closed suction drain inserted intra-articularly and subcutaneously, activated two hours postoperatively. No tranexamic acid was administered.
Faculity of Medicine
Idlib, Syria
Total Blood Loss
Total blood loss calculated using changes in hemoglobin concentration and the Good et al. formula.
Time frame: Within 72 hours after surgery
Hidden Blood Loss
Hidden blood loss calculated as total blood loss minus drainage volume.
Time frame: Within 72 hours after surgery
Drainage Volume
Total drainage collected through suction drains when applicable.
Time frame: 24 hours postoperatively
Number of Blood Transfusions
Number of patients receiving blood transfusions based on NIH Consensus criteria (Hb \< 8.0 g/dL, or \<10.0 g/dL with symptoms).
Time frame: During hospital stay (up to 7 days postoperatively)
Postoperative Limb Swelling
Change in limb circumference at thigh, knee, and calf compared with preoperative baseline.
Time frame: 1, 2, 4, and 6 weeks postoperatively
Wound-related Complications
Incidence of wound-related issues, including infection, hematoma, erythema, or superficial wound complications.
Time frame: Within 6 weeks after surgery
Thromboembolic Events (DVT/PE)
Incidence of deep vein thrombosis (DVT) confirmed with Doppler ultrasonography and pulmonary embolism (PE) if suspected clinically.
Time frame: Within 6 weeks after surgery
Postoperative Knee Range of Motion
Range of motion measured with a goniometer (flexion and extension).
Time frame: 2 months postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.