Evaluating the Effectiveness of Intramuscular Versus Intravenous Tranexamic Acid for Minimizing Blood Loss After Total Hip Arthroplasty: A Randomized Controlled Trial

Early Phase 1RecruitingNCT07817537

Alexandria University128 enrolled

Overview

Intramuscular vs. Intravenous Tranexamic Acid for Total Hip Arthroplasty

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

128

Conditions

Blood Loss After a Total Hip Replacement

Interventions

Tranexamic Acid (TXA) intarmuscularDRUG

Tranexamic acid 1 gram administered via deep intramuscular injection into the lateral thigh or deltoid muscle prior to surgery.

Tranexamic Acid (TXA) intravenousDRUG

Tranexamic acid 1 gram administered intravenously over 10 minutes, following standard protocols, prior to surgery.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult patients aged 18 years and older. 2. Scheduled to undergo elective primary total hip arthroplasty. 3. Able to provide informed consent. Exclusion Criteria: * 1\. History of renal failure or kidney transplant. 2. History of an arterial thromboembolic event (such as myocardial infarction or stroke) within the past year. 3\. Placement of an arterial stent within the past year. 4. History of deep venous thrombosis (DVT) or pulmonary embolism (PE). 5. Known contraindications to tranexamic acid. 6. Pregnancy or breastfeeding. 7. Refusal to participate or refusal to consent to receive blood products.

Locations (1)

Alexandria university main hospitals

Alexandria, Egypt

RECRUITING

Outcomes

Primary Outcomes

Change of Hemoglobin Concentration

Time frame: From baseline (preoperative) up to hospital discharge (typically 3-5 days postoperatively).

Secondary Outcomes

Postoperative Calculated Blood Loss

Volume of total blood loss calculated as a function of patient characteristics (sex, height, weight) and perioperative hemoglobin balance using standard Gross and Nadler mathematical formulas.

Time frame: From day 1 Up to hospital discharge.

Postoperative Calculated Hemoglobin Loss

Total mass of hemoglobin loss calculated based on patient baseline physical parameters and perioperative hemoglobin balance.

Time frame: From day 1 Up to hospital discharge.

Number of Blood Units Transfused

The total cumulative units of blood products administered per patient.

Time frame: From the start of surgery at day 1 up to hospital discharge.

Blood Transfusion Rate

The percentage/proportion of patients requiring allogeneic blood transfusion.

Time frame: From day 1 at the start of surgery up to hospital discharge

Length of Hospital Stay

Total number of days from surgical admission to official hospital discharge

Time frame: Up to 30 days postoperatively.

Incidence of Thromboembolic Events

Frequency of clinical or diagnostic thromboembolic complications (including deep venous thrombosis, pulmonary embolism, myocardial infarction, or stroke

Time frame: Up to 30 days postoperatively.

Central Contacts

Tarek I Ismail

CONTACT

+201001467166 Drtarek.anesth@gmail.com

Data from ClinicalTrials.gov

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