Local Subfascial and Intramuscular Tranexamic Acid Administration in Pediatric Patient Undergoing Scoliosis Surgery, Double Blind Randomized Control Trial

Scoliosis Clinical Trial

Official title:

Local Subfascial and Intramuscular Tranexamic Acid Administration in Pediatric Patient Undergoing Scoliosis Surgery, Double Blind Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04622397
• Other study ID #: tranexamic acid in scoliosis
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 10, 2021
• Est. completion date: December 29, 2021

Study information

• Verified date: November 2020
• Source: Cairo University
• Contact: Mina Adolf Helmy, MD
• Phone: 2001275716942
• Email: dr_mina20002010[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We hypothesized that local administration of tranexamic acid will minimize blood loss and blood product administration in pediatric patient undergoing scoliosis surgery

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 29, 2021
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Scoliosis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (4)

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. Review. — View 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. — View 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. — View Citation

Slaughter TF, Greenberg CS. Antifibrinolytic drugs and perioperative hemostasis. Am J Hematol. 1997 Sep;56(1):32-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraperative blood loss in both groups	amount of blood/kg(ml/kg)	period of surgery(1-2 hours)
Secondary	post-operative blood loss	amount of blood in drain after surgery	24 hours
Secondary	Blood product admenestration	units of blood given during surgery	duration of procedure(1-2 hours)