Does Tranexamic Acid Decrease Blood Loss in Pediatric Idiopathic Scoliosis Surgery?

NCT01813058 | Completed Phase 1 Results DMC

• 1 other identifier: IRB-P00003400
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescent idiopathic scoliosis surgery is an extensive procedure associated with significant blood loss frequently requiring the transfusion of blood. Tranexamic acid (TXA) is a synthetic antifibrinolytic (prevents breakdown of the blood clot) that has been used to extensively reduce transfusion in pediatric major surgery, including cardiac, craniofacial and orthopedic surgery. In this prospective randomized double-blinded study, the investigators wish to evaluate the hypothesis that TXA is more effective than standard of care at decreasing blood loss and blood transfusion perioperatively in children and adolescents undergoing idiopathic scoliosis surgery.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Tranexamic acid, Blood loss

Outcome Measures

Primary Outcomes (1)

• Perioperative Blood Loss

  Perioperative blood loss (during operation and for entire hospital admission)

  perioperarively - during entire hospital admission

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo ( 0.9% Normal saline) intravenously given as a 0.5 ml/kg loading dose over 15 minutes followed by a 0.1 ml/kg/hr continuous infusion throughout the surgery.

Drug: Placebo

Tranexamic acid

ACTIVE COMPARATOR

Tranexamic acid 100 mg/ml; 50 mg/kg loading dose = 0.5 ml/kg LD given over 15 minutes and 10 mg/kg/hr = 0.1 ml/kg/hr infusion for the duration of the surgery.

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to either: 1. placebo i.e. saline 0.9% (intravenous injection) 2. intravenous TXA given as a loading dose over 15 minutes of 50 mg/kg bolus ( within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery.

Also known as: Cyklokapron, TXA, TA

Tranexamic acid

Placebo DRUG

Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to: 1. Placebo ( 0.9% Normal saline) intravenously given as a 0.5 ml/kg loading dose over 15 minutes followed by a 0.1 ml/kg/hr continuous infusion throughout the surgery or 2. TXA as previously described.

Also known as: 0.9% Normal saline

Placebo

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents (age 10-21 yr) for elective Idiopathic scoliosis corrective surgery; posterior repair.

You may not qualify if:

• Preexisting coagulopathy, (INR\>1.4, PTT\>1.4xN, PT\>1.4xN, platelet count\<150,000/mm3), severe hematological disorders, hepatic failure, or renal failure. Ingestion of acetylsalicylate within 14 days or NSAIDs within 2 days of the scheduled surgery date; history of prior blood transfusion. Pre-donation of autologous blood. Patients having anterior-posterior repair.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Childrens Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

• Sethna NF, Zurakowski D, Brustowicz RM, Bacsik J, Sullivan LJ, Shapiro F. Tranexamic acid reduces intraoperative blood loss in pediatric patients undergoing scoliosis surgery. Anesthesiology. 2005 Apr;102(4):727-32. doi: 10.1097/00000542-200504000-00006.

  PMID: 15791100 BACKGROUND

• Goobie SM, Meier PM, Pereira LM, McGowan FX, Prescilla RP, Scharp LA, Rogers GF, Proctor MR, Meara JG, Soriano SG, Zurakowski D, Sethna NF. Efficacy of tranexamic acid in pediatric craniosynostosis surgery: a double-blind, placebo-controlled trial. Anesthesiology. 2011 Apr;114(4):862-71. doi: 10.1097/ALN.0b013e318210fd8f.

  PMID: 21364458 RESULT

• Goobie SM, Meier PM, Sethna NF, Soriano SG, Zurakowski D, Samant S, Pereira LM. Population pharmacokinetics of tranexamic acid in paediatric patients undergoing craniosynostosis surgery. Clin Pharmacokinet. 2013 Apr;52(4):267-76. doi: 10.1007/s40262-013-0033-1.

  PMID: 23371895 RESULT

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: susan Goobie, MD, FRCPC
• Organization: Boston Children's Hospital

susan.goobie@childrens.harvard.edu

6173667737

Study Officials

• Susan Goobie, MD, FRCPC

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Anesthesia

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: March 18, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: February 20, 2019
• Results First Posted: February 20, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)