NCT07494708

Hemoglobin Drop and Need for Blood Transfusion in Primary Knee Arthroplasty With or Without Drain Insertion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Shifa International Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Total knee arthroplasty is a common operation performed to relieve pain and improve movement in patients with severe knee joint disease, such as osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, or osteonecrosis. However, blood loss after surgery remains an important concern because it may lead to a fall in hemoglobin level and increase the need for blood transfusion. Blood transfusion may be necessary in some patients, but it also carries additional risks and cost. One practice that may influence postoperative blood loss is the use of a surgical drain. A drain is commonly placed at the end of surgery to remove blood and fluid from the operated area, but its benefit in total knee arthroplasty remains uncertain. Some studies suggest that drains may reduce blood collection inside the joint, whereas others suggest that they may increase overall blood loss by preventing the natural pressure effect that helps stop bleeding. This randomized clinical trial is being conducted to compare hemoglobin drop and blood transfusion requirement in patients undergoing primary unilateral total knee arthroplasty with or without drain insertion. A total of 102 patients will be enrolled and randomly allocated into two equal groups. In Group A, a closed suction drain will be inserted at the end of surgery. In Group B, no drain will be used. All operations will be performed using a standardized surgical technique, and all patients will receive similar perioperative care, including tranexamic acid, analgesia, thromboprophylaxis, and rehabilitation. Hemoglobin levels will be measured before surgery and again at 24 and 48 hours after surgery. The main outcomes will be the amount of hemoglobin drop after surgery and whether blood transfusion is required. Blood transfusion will be given according to the predefined hospital protocol when hemoglobin falls below 8 g/dL. The study hypothesis is that there is a significant difference in postoperative hemoglobin drop and blood transfusion requirement between patients undergoing primary knee arthroplasty with drain insertion and those undergoing surgery without drain insertion.

Conditions

• Knee Osteoarthritis
• Total Knee Arthroplasty

Interventions

Type	Name	Description
PROCEDURE	Closed Suction Drain Insertion	A closed suction drain will be placed at the surgical site at the end of primary total knee arthroplasty to allow postoperative drainage of blood and fluid.
OTHER	No Drain Placement	Primary total knee arthroplasty will be performed without insertion of a postoperative surgical drain. Standard perioperative management, including tranexamic acid, analgesia, thromboprophylaxis, and rehabilitation, will be provided similarly to the drain group.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2026-03-27
• Last updated: 2026-03-30

Locations

1 site across 1 country: Pakistan