Blood Loss After a Total Hip ReplacementEarly Phase 1NCT07817537
Evaluating the Effectiveness of Intramuscular Versus Intravenous Tranexamic Acid for Minimizing Blood Loss After Total Hip Arthroplasty: A Randomized Controlled Trial
A Early Phase 1 study testing Tranexamic Acid (TXA) intarmuscular and Tranexamic Acid (TXA) intravenous in people with Blood Loss After a Total Hip Replacement, run by Alexandria University at 1 site in Egypt.
Trial summary
Intramuscular vs. Intravenous Tranexamic Acid for Total Hip Arthroplasty Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Loss After a Total Hip Replacement
- What is being tested?
- Tranexamic Acid (TXA) intarmuscular and Tranexamic Acid (TXA) intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2026to 1 Mar 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years and older.
- Scheduled to undergo elective primary total hip arthroplasty.
- Able to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria university main hospitals
Alexandria
Rabab S Saber, +201223479339, Rabab.saleh@alexmed.edu.eg
About this study
Intramuscular vs. Intravenous Tranexamic Acid for Total Hip Arthroplasty
- Conditions
- Blood Loss After a Total Hip Replacement
- Being tested
- Tranexamic Acid (TXA) intarmuscular, Tranexamic Acid (TXA) intravenous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular TXA | Experimental | Tranexamic acid 1 gram administered via deep intramuscular injection into the lateral thigh or deltoid muscle prior to surgery. Anesthesia maintained with a balanced inhalational technique (isoflurane 1-1.5% in oxygen-enriched air) and baseline fluid therapy 10 ml per kg per hour of lactated Ringer's solution). Receives: Drug: Tranexamic Acid (TXA) intarmuscular |
| Intravenous TXA | Active comparator | Tranexamic acid 1 gram administered intravenously over 10 minutes, following standard protocols, prior to surgery. Anesthesia maintained with a balanced inhalational technique (isoflurane 1-1.5% in oxygen-enriched air) and baseline fluid therapy 10 ml per kg per hour of lactated Ringer's solution). Receives: Drug: Tranexamic Acid (TXA) intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Hemoglobin Concentration
Measured: From baseline (preoperative) up to hospital discharge (typically 3-5 days postoperatively).
Secondary outcomes (6)
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.
Measured: 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.
Measured: From day 1 Up to hospital discharge.
Number of Blood Units Transfused
The total cumulative units of blood products administered per patient.
Measured: From the start of surgery at day 1 up to hospital discharge.
Blood Transfusion Rate
The percentage/proportion of patients requiring allogeneic blood transfusion.
Measured: 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
Measured: 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
Measured: Up to 30 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start15 Jan 2026
- Primary completion15 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss After a Total Hip ReplacementStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817537
- Sponsor's protocol ID
- 0307144
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Intramuscular Versus Intravenous Tranexamic Acid for Minimizing Blood Loss After Total Hip Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07817537
- Acronym / sponsor ID
- 0307144
- Conditions
- Blood Loss After a Total Hip Replacement
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intramuscular vs. Intravenous Tranexamic Acid for Total Hip Arthroplasty
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramuscular TXA | Experimental | Drug: Tranexamic Acid (TXA) intarmuscularTranexamic acid 1 gram administered via deep intramuscular injection into the lateral thigh or deltoid muscle prior to surgery. Anesthesia maintained with a balanced inhalational technique (isoflurane 1-1.5% in oxygen-enriched air) and baseline fluid therapy 10 ml per kg per hour of lactated Ringer's solution). |
| Intravenous TXA | Active comparator | Drug: Tranexamic Acid (TXA) intravenousTranexamic acid 1 gram administered intravenously over 10 minutes, following standard protocols, prior to surgery. Anesthesia maintained with a balanced inhalational technique (isoflurane 1-1.5% in oxygen-enriched air) and baseline fluid therapy 10 ml per kg per hour of lactated Ringer's solution). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged 18 years and older.
- Scheduled to undergo elective primary total hip arthroplasty.
- Able to provide informed consent.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid (TXA) intarmuscularTranexamic acid 1 gram administered via deep intramuscular injection into the lateral thigh or deltoid muscle prior to surgery. | Drug | Intramuscular TXA |
| Tranexamic Acid (TXA) intravenousTranexamic acid 1 gram administered intravenously over 10 minutes, following standard protocols, prior to surgery. | Drug | Intravenous TXA |
Primary outcome
Change of Hemoglobin Concentration
Time frame: From baseline (preoperative) up to hospital discharge (typically 3-5 days postoperatively).
6 secondary outcomes
Postoperative Calculated Blood Loss
Time frame: From day 1 Up to hospital discharge.
Postoperative Calculated Hemoglobin Loss
Time frame: From day 1 Up to hospital discharge.
Number of Blood Units Transfused
Time frame: From the start of surgery at day 1 up to hospital discharge.
Blood Transfusion Rate
Time frame: From day 1 at the start of surgery up to hospital discharge
Length of Hospital Stay
Time frame: Up to 30 days postoperatively.
Incidence of Thromboembolic Events
Time frame: Up to 30 days postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tranexamic Acid (TXA) intarmuscular and Tranexamic Acid (TXA) intravenous in people with Blood Loss After a Total Hip Replacement, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tarek I Ismail (+201001467166, Drtarek.anesth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Hemoglobin Concentration (time frame: From baseline (preoperative) up to hospital discharge (typically 3-5 days postoperatively).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.