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

November 4, 2020 updated by: Mina Adolf Helmy, Cairo University
We hypothesized that local administration of tranexamic acid will minimize blood loss and blood product administration in pediatric patient undergoing scoliosis surgery

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group T (tranexamic acid),n=15
Group T: tranexamic acid 10 mg/kg will be injected locally
Drug: Tranexamic acid injection
Local subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision
PLACEBO_COMPARATOR: Group S (saline) (n=15)
Group S saline will be injected
Drug: Saline
Local subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 10, 2021

Primary Completion (ANTICIPATED)

November 29, 2021

Study Completion (ANTICIPATED)

December 29, 2021

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (ACTUAL)

November 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tranexamic acid in scoliosis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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