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We hypothesized that local administration of tranexamic acid will minimize blood loss and blood product administration in pediatric patient undergoing scoliosis surgery
Spine surgery in paediatrics is frequently associated with substantial blood loss.
Blood product adminestration in children has many complications that are not fully known.
There are many modalities currently available to reduce blood loss in pediatric patients.
Tranexamic acid is tissue plasminogen activator inhibitor that reduce perioperative blood loss.
To date, no studies have investigated effect of local administration of tranexamic acid in pediatric population undergoing scoliosis surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group T (tranexamic acid),n=15 | Active Comparator | Group T: tranexamic acid 10 mg/kg will be injected locally |
|
| Group S (saline) (n=15) | Placebo Comparator | Group S saline will be injected |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid injection | Drug | Local subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraperative blood loss in both groups | amount of blood/kg(ml/kg) | period of surgery(1-2 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| post-operative blood loss | amount of blood in drain after surgery | 24 hours |
| Blood product admenestration | units of blood given during surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mina Adolf Helmy, MD | Contact | 2001275716942 | dr_mina20002010@yahoo.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29303921 | Background | Bible JE, Mirza M, Knaub MA. Blood-loss Management in Spine Surgery. J Am Acad Orthop Surg. 2018 Jan 15;26(2):35-44. doi: 10.5435/JAAOS-D-16-00184. | |
| 26507915 | Background | Goobie SM. A blood transfusion can save a child's life or threaten it. Paediatr Anaesth. 2015 Dec;25(12):1182-3. doi: 10.1111/pan.12816. No abstract available. |
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randomized comparative study
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surgeon will be blinded to type of injection
| Saline | Drug | Local subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision |
|
| duration of procedure(1-2 hours) |
| 31934525 | Background | Mikhail C, Pennington Z, Arnold PM, Brodke DS, Chapman JR, Chutkan N, Daubs MD, DeVine JG, Fehlings MG, Gelb DE, Ghobrial GM, Harrop JS, Hoelscher C, Jiang F, Knightly JJ, Kwon BK, Mroz TE, Nassr A, Riew KD, Sekhon LH, Smith JS, Traynelis VC, Wang JC, Weber MH, Wilson JR, Witiw CD, Sciubba DM, Cho SK. Minimizing Blood Loss in Spine Surgery. Global Spine J. 2020 Jan;10(1 Suppl):71S-83S. doi: 10.1177/2192568219868475. Epub 2020 Jan 6. |
| 9298865 | Background | Slaughter TF, Greenberg CS. Antifibrinolytic drugs and perioperative hemostasis. Am J Hematol. 1997 Sep;56(1):32-6. doi: 10.1002/(sici)1096-8652(199709)56:13.0.co;2-3. |
| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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