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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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ClinicalTrials.gov Identifier: NCT04622397
Recruitment Status : Not yet recruiting
First Posted : November 10, 2020
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Mina Adolf Helmy, Cairo University

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

Condition or disease Intervention/treatment Phase
Blood Loss, Surgical Scoliosis Drug: Tranexamic acid injection Drug: Saline Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized comparative study
Masking: Single (Care Provider)
Masking Description: surgeon will be blinded to type of injection
Primary Purpose: Prevention
Official Title: Local Subfascial and Intramuscular Tranexamic Acid Administration in Pediatric Patient Undergoing Scoliosis Surgery, Double Blind Randomized Control Trial
Estimated Study Start Date : January 10, 2021
Estimated Primary Completion Date : November 29, 2021
Estimated Study Completion Date : December 29, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Scoliosis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Intraperative blood loss in both groups [ Time Frame: period of surgery(1-2 hours) ]
    amount of blood/kg(ml/kg)


Secondary Outcome Measures :
  1. post-operative blood loss [ Time Frame: 24 hours ]
    amount of blood in drain after surgery

  2. Blood product admenestration [ Time Frame: duration of procedure(1-2 hours) ]
    units of blood given during surgery


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04622397


Contacts
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Contact: Mina Adolf Helmy, MD 2001275716942 dr_mina20002010@yahoo.com

Sponsors and Collaborators
Cairo University
More Information
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Publications:

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Responsible Party: Mina Adolf Helmy, Doctor, Cairo University
ClinicalTrials.gov Identifier: NCT04622397    
Other Study ID Numbers: tranexamic acid in scoliosis
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Scoliosis
Blood Loss, Surgical
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hemorrhage
Pathologic Processes
 Intraoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants