Tranexamic Acid (TXA) Versus Epsilon Aminocaproic Acid (EACA) Versus Placebo for Spine Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by New York University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
New York University
ClinicalTrials.gov Identifier:
NCT00958581
First received: August 11, 2009
Last updated: August 12, 2009
Last verified: August 2009
  Purpose

Tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) have been reported to reduce blood loss in the cardiac surgery literature but they have not been reported in use head-to-head in the orthopedic surgery literature. In a randomized, double-blind, prospective study we believe that TXA will be more effective than both EACA and placebo at reducing blood loss for corrective spinal surgery.


Condition Intervention Phase
Scoliosis
Drug: Tranexamic Acid
Drug: Normal Saline
Drug: Epsilon aminocaproic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-blinded Single-site Control Study Comparing Blood Loss Prevention of Tranexamic Acid (TXA) to Epsilon Aminocaproic Acid (EACA) for Corrective Spinal Surgery

Resource links provided by NLM:


Further study details as provided by New York University:

Primary Outcome Measures:
  • Total Blood Loss over Course of Stay (Intraoperative and Postoperatively until discharge) [ Time Frame: 1 Week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total Units of Autologous and allogenic transfusion (Both intraoperatively and postoperatively until discharge) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Length of Hospital Stay from admission until Patient Discharge [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 390
Study Start Date: December 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Normal Saline
Patients infused with normal saline before and during the surgical procedure as a placebo.
Drug: Normal Saline
Experimental: Tranexamic acid
Patients receive TXA before and during the surgical case.
Drug: Tranexamic Acid
For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr.
Other Name: TXA
Experimental: Epsilon Aminocaproic Acid
Patients will receive EACA before and during the surgical case.
Drug: Epsilon aminocaproic acid
For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr.
Other Name: Amicar, EACA

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing thoracic and/or lumbar surgery for correction of adolescent idiopathic scoliosis, neuromuscular scoliosis, or adult deformity for correction of condition via posterior spinal fusion of 6 levels or greater.

Exclusion Criteria:

  • No renal dysfunction identified by elevated blood urea nitrogen (BUN) and creatinine (CR) or BUN to CR ratio greater than 20:1
  • Hold religious and/or other beliefs limiting blood transfusion
  • Currently use anti-coagulant medication or have past medical history leading to abnormal coagulation profile pre-operatively
  • Significant past medical history preventing the use of TXA or EACA described in the protocol
  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: NCT00958581

Contacts
Contact: Thomas J Errico, MD (212)263-7182 spinecore@hotmail.com
Contact: Kushagra Verma, MS (240)678-3725 vermak01@med.nyu.edu

Locations
United States, New York
New York University School of Medicine - Department of Orthopaedic Surgery - Spine Recruiting
New York, New York, United States, 10016
Principal Investigator: Thomas J Errico, MD         
Principal Investigator: Baron S Lonner, MD         
Sub-Investigator: Kushagra Verma, MS         
Sponsors and Collaborators
New York University
Investigators
Principal Investigator: Thomas J Errico, MD New York University School of Medicine - Department of Orthopaedic Surgery
Principal Investigator: Baron S Lonner, MD New York University - Department of Orthopaedic Surgery
  More Information

No publications provided by New York University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York University School of Medicine - Department of Orthopaedic Surgery
ClinicalTrials.gov Identifier: NCT00958581     History of Changes
Other Study ID Numbers: TXA, Amicar, Placebo
Study First Received: August 11, 2009
Last Updated: August 12, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tranexamic Acid
Aminocaproic 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 October 19, 2014