Intraoperative Blood LossNCT04811313
Tranexamic Acid in Pediatric Undergoing Proximal Femoral Osteotomies and/or Acetabular Osteotomy
A study testing Tranexamic acid and caudal epidural block in people with Intraoperative Blood Loss and Pediatric, run by Assiut University at 1 site in Egypt.
Trial summary
Surgical hip reconstruction reduces the hip joint through soft tissue releases and osteotomies of the femur and/or pelvis. Blood loss and subsequent blood transfusion are normal consequences of hip reconstruction. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Intraoperative Blood Loss, Pediatric, Orthopedic Disorder
- What is being tested?
- Tranexamic acid and caudal epidural block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Apr 2025to Mar 2026
- Phase
- Interventional
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ASA I - II
- Scheduled for acetabular osteotomy and/or proximal femoral derotation osteotomies.
Who cannot join
- Patient's guardian refusal to participate in the study.
- Children known to have pre-existing bleeding or coagulation disorders.
- Children with anemia; defined according to (WHO ) cutoffs as Hb level<11g/dl for girls and <12g/dl for boys
- History of epilepsy.
- History of renal insufficiency or failure
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
Assiut University
Asyut, 71515
Shimaa A Hassan, MD, 01002953253, shimaa.abbas@med.aun.edu.eg
About this study
Official title: Impact of Tranexamic Acid Use on Blood Loss and Transfusion Rates After Hip Reconstruction in Children, A Randomized Controlled Trial
Surgical hip reconstruction reduces the hip joint through soft tissue releases and osteotomies of the femur and/or pelvis. Blood loss and subsequent blood transfusion are normal consequences of hip reconstruction.
Read the detailed description
the use of antifibrinolytics (AFs) to limit blood loss peri-operatively has been popularized in certain subspecialties. AFs have been studied extensively in adults undergoing various orthopedic procedures including spine and total joint arthroplasty, and have been proven to reduce blood loss and reduce the risk of blood transfusion. Similarly, AFs are used in pediatric patients undergoing cardiac surgery as well as craniofacial operations. Tranexamic acid (TXA) is a synthetic anti-fibrinolytic agent that works by reversibly blocking plasminogen and thereby promoting hemostasis through the prevention of fibrin degradation. Current literature investigating the safety and effectiveness of TXA in children undergoing orthopedic procedures is limited.
We hypothesize that patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA.
- Conditions
- Intraoperative Blood Loss, Pediatric, Orthopedic Disorder
- Being tested
- Tranexamic acid, caudal epidural block, Placebo
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called Kapron
patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA
caudal epidural blockProcedure or surgery
Also called bupivacaine 0.25%
regional anesthesia in orthopedic procedures are known to help reduction of intraoperative blood loss
PlaceboOther
participants will receive standard care but neither TXA nor caudal epidural block
| Study group | Role | What they receive |
|---|---|---|
| T group | Active comparator | each participant will receive 15 mg/kg of tranexamic acid diluted in a 10 mL syringe slowly over 10-15 minutes, 15 minutes before skin incision. Receives: Drug: Tranexamic acid |
| TC group | Active comparator | each participant will receive 10 mg/kg of tranexamic acid diluted in a 5 mL syringe slowly over 5 minutes, 15 minutes before skin incision, and A caudal epidural block with 1 mL/kg of 0.25% bupivacaine. Receives: Drug: Tranexamic acid; Procedure: caudal epidural block |
| C group | Active comparator | each participant will receive a caudal epidural block with 1 mL/kg of 0.25% bupivacaine. Receives: Procedure: caudal epidural block |
| P group | Placebo comparator | participants will receive the regular standard care without adding tranexamic acid or caudal epidural block Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of intraoperative blood loss
calculated from the fall in red blood cell volume
Measured: 24 hours
Secondary outcomes (3)
Rate of blood transfusion
either intraoperative or postoperative blood transfusion
Measured: 24 hours
Incidence of adverse effects or complications of TXA
e.g. thromboembolic events or perioperative seizures will be managed and recorded
Measured: 24 hours
length of hospital stay
readiness for hospital discharge
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start3 Apr 2025
- Primary completionJan 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Blood LossStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Abbas Hassan, Assiut University
- Investigators
- Amr M Sleem, M.D., Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811313
- Sponsor's protocol ID
- tranexamic acid in pediatric
- Status last verified
- Nov 2025
- First submitted
- 19 Mar 2021
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Tranexamic Acid Use on Blood Loss and Transfusion Rates After Hip Reconstruction in Children, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04811313
- Acronym / sponsor ID
- tranexamic acid in pediatric
- Conditions
- Intraoperative Blood Loss, Pediatric, Orthopedic Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 23 Mar 2021 (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.
Surgical hip reconstruction reduces the hip joint through soft tissue releases and osteotomies of the femur and/or pelvis. Blood loss and subsequent blood transfusion are normal consequences of hip reconstruction.
Detailed description
the use of antifibrinolytics (AFs) to limit blood loss peri-operatively has been popularized in certain subspecialties. AFs have been studied extensively in adults undergoing various orthopedic procedures including spine and total joint arthroplasty, and have been proven to reduce blood loss and reduce the risk of blood transfusion. Similarly, AFs are used in pediatric patients undergoing cardiac surgery as well as craniofacial operations. Tranexamic acid (TXA) is a synthetic anti-fibrinolytic agent that works by reversibly blocking plasminogen and thereby promoting hemostasis through the prevention of fibrin degradation. Current literature investigating the safety and effectiveness of TXA in children undergoing orthopedic procedures is limited.
We hypothesize that patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| T group | Active comparator | Drug: Tranexamic acideach participant will receive 15 mg/kg of tranexamic acid diluted in a 10 mL syringe slowly over 10-15 minutes, 15 minutes before skin incision. |
| TC group | Active comparator | Drug: Tranexamic acid, Procedure: caudal epidural blockeach participant will receive 10 mg/kg of tranexamic acid diluted in a 5 mL syringe slowly over 5 minutes, 15 minutes before skin incision, and A caudal epidural block with 1 mL/kg of 0.25% bupivacaine. |
| C group | Active comparator | Procedure: caudal epidural blockeach participant will receive a caudal epidural block with 1 mL/kg of 0.25% bupivacaine. |
| P group | Placebo comparator | Other: Placeboparticipants will receive the regular standard care without adding tranexamic acid or caudal epidural block |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- ASA I - II
- Scheduled for acetabular osteotomy and/or proximal femoral derotation osteotomies.
Key exclusion criteria (5 listed)
- Patient's guardian refusal to participate in the study.
- Children known to have pre-existing bleeding or coagulation disorders.
- Children with anemia; defined according to (WHO ) cutoffs as Hb level<11g/dl for girls and <12g/dl for boys
- History of epilepsy.
- History of renal insufficiency or failure
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 acidAlso: Kapronpatients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA | Drug | T group, TC group |
| caudal epidural blockAlso: bupivacaine 0.25%regional anesthesia in orthopedic procedures are known to help reduction of intraoperative blood loss | Procedure or surgery | C group, TC group |
| Placeboparticipants will receive standard care but neither TXA nor caudal epidural block | Other | P group |
Primary outcome
amount of intraoperative blood loss
Time frame: 24 hours
calculated from the fall in red blood cell volume
3 secondary outcomes
Rate of blood transfusion
Time frame: 24 hours
Incidence of adverse effects or complications of TXA
Time frame: 24 hours
length of hospital stay
Time frame: 24 hours
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 17 Nov 2025.
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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.
Amr M Sleem, M.D. study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid and caudal epidural block in people with Intraoperative Blood Loss and Pediatric, run by Assiut 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 2 inclusion and 5 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 17 Nov 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Shimaa A Hassan, M.D. (01002953253, shimaa.abbas@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of intraoperative blood loss (time frame: 24 hours). 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 17 Nov 2025.