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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01813058
First received: February 25, 2013
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Adolescent Idiopathic Scoliosis
Drug: Tranexamic Acid
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of Intravenous Tranexamic Acid in Decreasing Blood Loss in Pediatric Idiopathic Scoliosis Surgery?

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Perioperative blood loss [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Perioperative blood loss ( i.e. intraoperative blood loss plus 24 hour postoperative blood loss) will be measured in mL/kg.


Secondary Outcome Measures:
  • Pharmacokinetic profile [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Population pharmocokinetic Nonlinear regression modeling of measured TXA concentrations will be conducted using NONMEM 7 software (ICON Development Solutions, Ellicott City, MD).

  • DNA analysis of PAI-1 gene polymorphism [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    DNA purification will be conducted using proteinase K, phenol-chloroform extraction, and ethanol precipitation. Analysis of PAI-1 gene polymorphism will be performed using primers and restriction endonuclease digestion.


Other Outcome Measures:
  • Plasma concentration of tranexamic acid [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Plasma tranexamic acid concentrations (ug/mL) will be measured by GC-MS.

  • Perioperative transfusion of Packed red blood cells(PRBC) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    PRBC volume will be measured in mL/kg.

  • Plasminogen activator inhibitor-1 (PAI-1) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Analysis of PAI-1 is done by ELISA, using the R&D Systems Quantikine kit (DSE100)


Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
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

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.
Other Name: 0.9% Normal saline
Active Comparator: Tranexamic acid
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

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.
Other Name: Cyklokapron, TXA, TA

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  Eligibility

Ages Eligible for Study:   10 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813058

Contacts
Contact: Susan Goobie, MD, FRCPC 6173557737 susan.goobie@childrens.harvard.edu
Contact: Timothy Hresko, MD 6173556000 Timothy.hresko@childrens.harvard.edu

Locations
United States, Massachusetts
Boston Childrens Hospital Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Susan Goobie, Md, FRCPC         
Sub-Investigator: Timothy Hresko, MD         
Sub-Investigator: Navil Sethna, MD         
Sub-Investigator: Mary Ellen McCann, MD         
Sub-Investigator: Robert Brustowicz, MD         
Sub-Investigator: Andres Navedo, MD         
Sub-Investigator: Luis Pereira, PhD         
Sub-Investigator: John Emans, MD         
Sub-Investigator: Daniel Hedequest, MD         
Sub-Investigator: Lawerence Karlin, MD         
Sub-Investigator: David Zurakowski, PhD         
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Susan Goobie, MD, FRCPC Children's Hospital Boston
  More Information

Publications:
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; 114: 862-71

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01813058     History of Changes
Other Study ID Numbers: IRB-P00003400
Study First Received: February 25, 2013
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Tranexamic acid, Blood loss

Additional relevant MeSH terms:
Hemorrhage
Scoliosis
Pathologic Processes
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014