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NCT Number: NCT07089251

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

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

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

King Abdulaziz Medical City, Ministry of National Guard - Health Affairs

Riyadh, Riyadh Region, Saudi Arabia

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low-dose epinephrine and tranexamic acid

Drug

low-dose epinephrine and tranexamic acid

Tranexamic Acid (TXA) treatment

Drug

Tranexamic Acid

Primary outcomes

  1. Perioperative blood loss

    Time frame: 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 outcomes

  1. Thromboembolic complications

    Time frame: Daily, till post-operative day 5

  2. Hospitalization duration

    Time frame: Daily, till post-operative day 5

  3. Drug side effects (epinephrine + tranexamic acid)

    Time frame: Daily, till post-operative day 5

  4. Complications

    Time frame: Daily, till post-operative day 5

    VTE, SSI, UTI, AKI, Cardiac Arrhythmias, Stroke

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Turki Althunayan

CONTACT

[email protected]

+966 55 994 4782

Sponsors and collaborators

Lead sponsor

King Abdullah International Medical Research Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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