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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00958581
First Posted: August 13, 2009
Last Update Posted: December 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
New York University School of Medicine
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 School of Medicine:

Primary Outcome Measures:
  • Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge) [ Time Frame: 1 Week ]

Secondary Outcome Measures:
  • Total Units of Autologous and Allogenic Transfusion (Both Intraoperatively and Postoperatively Until Discharge) [ Time Frame: 1 week ]
  • Length of Hospital Stay From Admission Until Patient Discharge [ Time Frame: 1 week ]

Enrollment: 177
Study Start Date: December 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (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
Normal saline of same volume as the intervention group will be given as the intervention group as a loading dose and maintenance dose.
Other Name: Placebo
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

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00958581


Locations
United States, New York
New York University School of Medicine - Department of Orthopaedic Surgery - Spine
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00958581     History of Changes
Other Study ID Numbers: 08-779
First Submitted: August 11, 2009
First Posted: August 13, 2009
Results First Submitted: November 14, 2017
Results First Posted: December 12, 2017
Last Update Posted: December 12, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by New York University School of Medicine:
antifibrinolytics

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Tranexamic Acid
Aminocaproic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants