Blood Loss After a Total Hip Replacement
Conditions
Brief summary
Intramuscular vs. Intravenous Tranexamic Acid for Total Hip Arthroplasty
Interventions
DRUGTranexamic Acid (TXA) intarmuscular
Tranexamic acid 1 gram administered via deep intramuscular injection into the lateral thigh or deltoid muscle prior to surgery.
DRUGTranexamic Acid (TXA) intravenous
Tranexamic acid 1 gram administered intravenously over 10 minutes, following standard protocols, prior to surgery.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of Hemoglobin Concentration | From baseline (preoperative) up to hospital discharge (typically 3-5 days postoperatively). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Calculated Blood Loss | From day 1 Up to hospital discharge. | 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. |
| Postoperative Calculated Hemoglobin Loss | From day 1 Up to hospital discharge. | Total mass of hemoglobin loss calculated based on patient baseline physical parameters and perioperative hemoglobin balance. |
| Number of Blood Units Transfused | From the start of surgery at day 1 up to hospital discharge. | The total cumulative units of blood products administered per patient. |
| Blood Transfusion Rate | From day 1 at the start of surgery up to hospital discharge | The percentage/proportion of patients requiring allogeneic blood transfusion. |
| Length of Hospital Stay | Up to 30 days postoperatively. | Total number of days from surgical admission to official hospital discharge |
| Incidence of Thromboembolic Events | Up to 30 days postoperatively. | Frequency of clinical or diagnostic thromboembolic complications (including deep venous thrombosis, pulmonary embolism, myocardial infarction, or stroke |
Countries
Egypt
Contacts
CONTACTTarek I Ismail
Outcome results
None listed