Local Subfascial and Intramuscular Tranexamic Acid Administration in Pediatric Patient Undergoing Scoliosis Surgery, Double Blind Randomized Control Trial
NCT ID: NCT04622397
Last Updated: 2020-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-01-10
2021-12-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Group T (tranexamic acid),n=15
Group T: tranexamic acid 10 mg/kg will be injected locally
Tranexamic acid injection
Local subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision
Group S (saline) (n=15)
Group S saline will be injected
Saline
Local subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision
Interventions
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Tranexamic acid injection
Local subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision
Saline
Local subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision
Eligibility Criteria
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Inclusion Criteria
* Of both sexes
* American society of anesthesiologist (ASA) physical status classification class I
* Undergoing general anesthesia for scoliosis surgery
Exclusion Criteria
* Known allergy to tranexamic acid
* Bleeding disorders (INR \>1.4,Platelet count\< 75000)
2 Years
12 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Mina Adolf Helmy
Doctor
Central Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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tranexamic acid in scoliosis
Identifier Type: -
Identifier Source: org_study_id