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

NCT ID: NCT07089251

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2027-06-24

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Epinephrine + Tranexamic Acid Group

The experimental group will receive both epinephrine and tranexamic acid

Group Type EXPERIMENTAL

low-dose epinephrine and tranexamic acid

Intervention Type DRUG

low-dose epinephrine and tranexamic acid

Tranexamic Acid Group

The comparator group will receive only tranexamic acid

Group Type ACTIVE_COMPARATOR

Tranexamic Acid (TXA) treatment

Intervention Type DRUG

Tranexamic Acid

Interventions

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low-dose epinephrine and tranexamic acid

low-dose epinephrine and tranexamic acid

Intervention Type DRUG

Tranexamic Acid (TXA) treatment

Tranexamic Acid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Abdullah International Medical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Wazzan Saleh ALJuhani

Principal investigator, Orthopedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wazzan Aljuhani, MD, FRCSC, MBA, MMEd

Role: PRINCIPAL_INVESTIGATOR

King Abdulaziz Medical City, MNGHA

Locations

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

Riyadh, Riyadh Region, Saudi Arabia

Site Status RECRUITING

Countries

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Saudi Arabia

Central Contacts

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Dr. Turki Althunayan

Role: CONTACT

+966 55 994 4782

Other Identifiers

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ICTR24/002/9

Identifier Type: -

Identifier Source: org_study_id

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