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
Recruitment status was Recruiting
Sponsor:
New York University
Information provided by:
New York University
ClinicalTrials.gov Identifier:
NCT00958581
First received: August 11, 2009
Last updated: August 12, 2009
Last verified: August 2009
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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
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:
|
Scoliosis Spinal Curvatures Spinal Diseases Bone Diseases Musculoskeletal Diseases 6-Aminocaproic Acid 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 May 16, 2013