The Perioperative Outcome of Epinephrine Infusion and Tranexamic Acid in Knee Arthroplasty Surgery

Not Applicable

Recruiting

• Conditions: Knee Arthroplasty, Total; Knee Arthritis, Osteoarthritis; Total Knee Anthroplasty; Blood Loss; Tranexamic Acid Use; Epinephrine
• Interventions: Drug: low-dose epinephrine and tranexamic acid; Drug: Tranexamic Acid (TXA) treatment

• Registration Number: NCT07089251
• Lead Sponsor: King Abdullah International Medical Research Center

Brief Summary

The aim of this clinical trial is to evaluate the effect of administering low-dose epinephrine and tranexamic acid on perioperative blood loss, thromboembolic complications, and hospitalization duration in patients undergoing knee joint arthroplasty.

Also aim to evaluate the effect of administering low-dose epinephrine and tranexamic acid on perioperative thromboembolic complications, and hospitalization duration

Detailed Description

Patients will be randomly divided into two groups: one receiving intravenous low-dose epinephrine and tranexamic acid, while the other will receive TXA alone as the control. Randomization to be done using a computer-generated table.

The study will be done a superiority clinical trial. with an estimated 24 hour blood loss of 300 ml, with standard deviation of 150 ml. a power of 80% and alpha 5%, an estimated sample size of 80 is needed to detect a difference.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-09
• Study Start: 2025-07-15
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28
• Primary Completion: 2027-06-24
• Study Completion: 2027-06-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients undergoing knee joint arthroplasty.
• Saudi and Non-Saudi Patient.
• Patients who have Complete medical record.

Exclusion Criteria

• End stage renal disease
• Liver cirrhosis
• Coagulopathy
• Pre-operative Hgb <10 5.
• History of cerebrovascular accident or myocardial infarction in past 12 months.
• History of Heart failure.
• History of arrhythmia.
• History of pheochromocytoma, thyrotoxicosis and glaucoma.
• Pregnancy or breast feeding
• History of Deep venous thrombosis or pulmonary embolism
• Allergy to epinephrine or tranexamic acid

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epinephrine + Tranexamic Acid Group	low-dose epinephrine and tranexamic acid	The experimental group will receive both epinephrine and tranexamic acid
Tranexamic Acid Group	Tranexamic Acid (TXA) treatment	The comparator group will receive only tranexamic acid

Primary Outcome Measures

Name	Time	Method
Perioperative blood loss	Daily, till post-operative day 5	Calculated 24 h blood loss in mL, Hidden blood loss in mL, Hemoglobin levels in g/dL, Hematocrit levels as a percentage, Platelets count in cells/µL.

Secondary Outcome Measures

Name	Time	Method
Thromboembolic complications	Daily, till post-operative day 5
Hospitalization duration	Daily, till post-operative day 5
Drug side effects (epinephrine + tranexamic acid)	Daily, till post-operative day 5
Complications	Daily, till post-operative day 5	VTE, SSI, UTI, AKI, Cardiac Arrhythmias, Stroke

Trial Locations

Locations (1)

King Abdulaziz Medical City, Ministry of National Guard - Health Affairs; 🇸🇦 Riyadh, Saudi Arabia