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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| C group | Active Comparator | each participant will receive a caudal epidural block with 1 mL/kg of 0.25% bupivacaine. |
|
| P group | Placebo Comparator | participants will receive the regular standard care without adding tranexamic acid or caudal epidural block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA |
|
| Measure | Description | Time Frame |
|---|---|---|
| amount of intraoperative blood loss | calculated from the fall in red blood cell volume | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of blood transfusion | either intraoperative or postoperative blood transfusion | 24 hours |
| Incidence of adverse effects or complications of TXA | e.g. thromboembolic events or perioperative seizures will be managed and recorded |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shimaa A Hassan, M.D. | Contact | 01002953253 | shimaa.abbas@med.aun.edu.eg | |
| Amira A Abdel-rahman, M.B.B.CH | Contact | 01002595850 | amiraali441994@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Amr M Sleem, M.D. | Assiut University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut University | Recruiting | Asyut | 71515 | Egypt |
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| caudal epidural block | Procedure | regional anesthesia in orthopedic procedures are known to help reduction of intraoperative blood loss |
|
|
| Placebo | Other | participants will receive standard care but neither TXA nor caudal epidural block |
|
| 24 hours |
| length of hospital stay | readiness for hospital discharge | 24 hours |