Intraosseous Tranexamic Acid for Reducing Blood Loss in Total Knee Arthroplasty

NCT07853885 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: SL-KY-2026-96
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single-center, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of local intraosseous tranexamic acid administration for reducing perioperative blood loss in patients undergoing primary unilateral total knee arthroplasty (TKA). A total of 70 patients with primary knee osteoarthritis will be randomly assigned in a 1:1 ratio to either the tranexamic acid group or the placebo control group. Before skin incision, participants in the experimental group will receive local intraosseous tranexamic acid, while participants in the control group will receive an equal volume of normal saline using the same injection procedure. The primary outcome is total perioperative blood loss. Secondary outcomes include postoperative hemoglobin reduction, transfusion requirements, pain, knee swelling, range of motion, functional recovery, length of hospital stay, and postoperative complications. Participants will be followed for up to 3 months after surgery.

Conditions

Knee Osteoarthritis

Keywords

Total Knee Arthroplasty; Tranexamic Acid; Intraosseous Injection

Outcome Measures

Primary Outcomes (1)

• Total Perioperative Blood Loss

  Total perioperative blood loss will be calculated in milliliters (mL) using perioperative hematologic measurements and estimated blood volume based on preoperative and postoperative laboratory values.

  From preoperative baseline through postoperative day 3

Secondary Outcomes (12)

• Maximum Decrease in Hemoglobin

  From preoperative baseline through postoperative day 3

• Allogeneic Red Blood Cell Transfusion Rate

  From the start of surgery through hospital discharge,an anticipated average of 5-7 days.

• Volume of Allogeneic Red Blood Cell Transfusion

  From the start of surgery through hospital discharge，an anticipated average of 5-7 days.

• Pain Intensity at Rest

  Postoperative day 1, postoperative day 3

• Pain Intensity During Activity

  Postoperative day 1, postoperative day 3

Study Arms (2)

Intraosseous Tranexamic Acid

EXPERIMENTAL

Participants assigned to this arm will receive a total dose of 2 g of tranexamic acid by local intraosseous injection before skin incision during primary unilateral total knee arthroplasty. Tranexamic acid 1 g will be administered into the cancellous bone of the tibial plateau, and the remaining 1 g will be administered into the medial and lateral condyles of the distal femur. All other surgical, analgesic, and rehabilitation procedures will follow the standardized perioperative protocol.

Drug: Tranexamic Acid

Normal Saline Placebo

PLACEBO COMPARATOR

Participants assigned to this arm will undergo the same intraosseous injection procedure before skin incision during primary unilateral total knee arthroplasty but will receive an equal volume of normal saline instead of tranexamic acid. All other surgical, analgesic, and rehabilitation procedures will be identical to those in the experimental arm.

Drug: Normal Saline

Interventions

Tranexamic Acid DRUG

A total dose of 2 g of tranexamic acid will be administered by local intraosseous injection before skin incision during primary unilateral total knee arthroplasty. Of the total dose, 1 g will be injected into the cancellous bone of the tibial plateau, and 1 g will be injected into the medial and lateral condyles of the distal femur. The intervention will be administered using a standardized intraosseous injection technique.

Intraosseous Tranexamic Acid

Normal Saline DRUG

Normal saline will be administered by the same local intraosseous injection procedure before skin incision during primary unilateral total knee arthroplasty. The volume, injection sites, timing, and administration procedure will be matched to those used in the experimental group.

Normal Saline Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 to 85 years.
• Diagnosis of primary knee osteoarthritis.
• Scheduled to undergo primary unilateral total knee arthroplasty.
• American Society of Anesthesiologists (ASA) physical status classification I to III.
• Willing to participate in the study and able to provide written informed consent.

You may not qualify if:

• Known allergy or hypersensitivity to tranexamic acid.
• History of thromboembolic disease, including deep vein thrombosis or pulmonary embolism.
• Known hypercoagulable state or current use of anticoagulant therapy, except for protocol-permitted perioperative anticoagulation
• Severe cardiac, hepatic, or renal dysfunction.
• History of vascular stent implantation or peripheral vascular disease.
• Active infection or previous surgery on the study knee.
• Abnormal coagulation function, including an international normalized ratio (INR) greater than 1.5.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• The Second Affiliated Hospital of Kunming Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650000, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ning Lu

  The Second Affiliated Hospital of Kunming Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NIng Lu

CONTACT

+86-13888574273; luningwei2@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the intraosseous tranexamic acid group or the placebo control group and will remain in the assigned group throughout the study.

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: October 2, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)