Back to resultsLocal Subfascial and Intramuscular Tranexamic Acid Administration in Pediatric Patient Undergoing Scoliosis Surgery, Double Blind Randomized Control Trial
Primary Purpose
Blood Loss, Surgical, Scoliosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tranexamic acid injection
Saline
Sponsored by
About this trial
This is an interventional prevention trial for Blood Loss, Surgical
Eligibility Criteria
Inclusion Criteria:
- Children aged 2-12 years
- Of both sexes
- American society of anesthesiologist (ASA) physical status classification class I
- Undergoing general anesthesia for scoliosis surgery
Exclusion Criteria:
- Parents' refusal of regional block
- Known allergy to tranexamic acid
- Bleeding disorders (INR >1.4,Platelet count< 75000)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group T (tranexamic acid),n=15
Group S (saline) (n=15)
Arm Description
Group T: tranexamic acid 10 mg/kg will be injected locally
Group S saline will be injected
Outcomes
Primary Outcome Measures
Intraperative blood loss in both groups
amount of blood/kg(ml/kg)
Secondary Outcome Measures
post-operative blood loss
amount of blood in drain after surgery
Blood product admenestration
units of blood given during surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04622397
Brief Title
Local Subfascial and Intramuscular Tranexamic Acid Administration in Pediatric Patient Undergoing Scoliosis Surgery, Double Blind Randomized Control Trial
Official Title
Local Subfascial and Intramuscular Tranexamic Acid Administration in Pediatric Patient Undergoing Scoliosis Surgery, Double Blind Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2021 (Anticipated)
Primary Completion Date
November 29, 2021 (Anticipated)
Study Completion Date
December 29, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
We hypothesized that local administration of tranexamic acid will minimize blood loss and blood product administration in pediatric patient undergoing scoliosis surgery
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical, Scoliosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized comparative study
Masking
Care Provider
Masking Description
surgeon will be blinded to type of injection
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group T (tranexamic acid),n=15
Arm Type
Active Comparator
Arm Description
Group T: tranexamic acid 10 mg/kg will be injected locally
Arm Title
Group S (saline) (n=15)
Arm Type
Placebo Comparator
Arm Description
Group S saline will be injected
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid injection
Intervention Description
Local subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Local subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision
Primary Outcome Measure Information:
Title
Intraperative blood loss in both groups
Description
amount of blood/kg(ml/kg)
Time Frame
period of surgery(1-2 hours)
Secondary Outcome Measure Information:
Title
post-operative blood loss
Description
amount of blood in drain after surgery
Time Frame
24 hours
Title
Blood product admenestration
Description
units of blood given during surgery
Time Frame
duration of procedure(1-2 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children aged 2-12 years
Of both sexes
American society of anesthesiologist (ASA) physical status classification class I
Undergoing general anesthesia for scoliosis surgery
Exclusion Criteria:
Parents' refusal of regional block
Known allergy to tranexamic acid
Bleeding disorders (INR >1.4,Platelet count< 75000)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mina Adolf Helmy, MD
Phone
2001275716942
Email
dr_mina20002010@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29303921
Citation
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.
Results Reference
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PubMed Identifier
26507915
Citation
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.
Results Reference
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PubMed Identifier
31934525
Citation
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.
Results Reference
background
PubMed Identifier
9298865
Citation
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.
Results Reference
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Local Subfascial and Intramuscular Tranexamic Acid Administration in Pediatric Patient Undergoing Scoliosis Surgery, Double Blind Randomized Control Trial
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