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

King Abdullah International Medical Research Center

Status and phase: Enrolling; Phase 4

Conditions: Tranexamic Acid Use; Epinephrine; Knee Arthroplasty, Total; Total Knee Anthroplasty; Blood Loss; Knee Arthritis, Osteoarthritis

Treatments: Drug: low-dose epinephrine and tranexamic acid; Drug: Tranexamic Acid (TXA) treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07089251

ICTR24/002/9

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Epinephrine + Tranexamic Acid Group

Experimental group

Description:

The experimental group will receive both epinephrine and tranexamic acid

Treatment:

Drug: low-dose epinephrine and tranexamic acid

Tranexamic Acid Group

Active Comparator group

Description:

The comparator group will receive only tranexamic acid

Treatment:

Drug: Tranexamic Acid (TXA) treatment