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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04622397

Enrollment

Registered

2020-11-10

Start date

2021-01-10

Completion date

2021-12-29

Last updated

2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss, Surgical, Scoliosis

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.

Interventions

DRUGTranexamic acid injection

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

DRUGSaline

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Caregiver)

Masking description

surgeon will be blinded to type of injection

Intervention model description

randomized comparative study

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Intraperative blood loss in both groups	period of surgery(1-2 hours)	amount of blood/kg(ml/kg)

Secondary

Measure	Time frame	Description
post-operative blood loss	24 hours	amount of blood in drain after surgery
Blood product admenestration	duration of procedure(1-2 hours)	units of blood given during surgery

Contacts

Primary ContactMina Adolf Helmy, MD

dr_mina20002010@yahoo.com2001275716942

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026