NCT04622397

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 10, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2021

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

November 4, 2020

Last Update Submit

November 4, 2020

Conditions

Blood Loss, SurgicalScoliosis

Outcome Measures

Primary Outcomes (1)

  • Intraperative blood loss in both groups

    amount of blood/kg(ml/kg)

    period of surgery(1-2 hours)

Secondary Outcomes (2)

  • post-operative blood loss

    24 hours

  • Blood product admenestration

    duration of procedure(1-2 hours)

Study Arms (2)

Group T (tranexamic acid),n=15

ACTIVE COMPARATOR

Group T: tranexamic acid 10 mg/kg will be injected locally

Drug: Tranexamic acid injection

Group S (saline) (n=15)

PLACEBO COMPARATOR

Group S saline will be injected

Drug: Saline

Interventions

Tranexamic acid injectionDRUG

Local subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision

Group T (tranexamic acid),n=15
SalineDRUG

Local subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision

Group S (saline) (n=15)

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 2-12 years
  • Of both sexes
  • American society of anesthesiologist (ASA) physical status classification class I
  • Undergoing general anesthesia for scoliosis surgery

You may not qualify if:

  • Parents' refusal of regional block
  • Known allergy to tranexamic acid
  • Bleeding disorders (INR \>1.4,Platelet count\< 75000)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 29303921BACKGROUND

  • 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.

    PMID: 26507915BACKGROUND

  • 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.

    PMID: 31934525BACKGROUND

  • 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.

    PMID: 9298865BACKGROUND

MeSH Terms

Conditions

Blood Loss, SurgicalScoliosis

Interventions

Tranexamic AcidSodium Chloride

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative ComplicationsSpinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Mina Adolf Helmy, MD

CONTACT

2001275716942dr_mina20002010@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
surgeon will be blinded to type of injection
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized comparative study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 10, 2020

Study Start

January 10, 2021

Primary Completion

November 29, 2021

Study Completion

December 29, 2021

Last Updated

November 10, 2020

Record last verified: 2020-11