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

NCT00958581 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 08-779
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Scoliosis

Keywords

antifibrinolytics

Outcome Measures

Primary Outcomes (1)

• Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge)

  1 Week

Secondary Outcomes (2)

• Total Units of Autologous and Allogenic Transfusion (Both Intraoperatively and Postoperatively Until Discharge)

  1 week

• Length of Hospital Stay From Admission Until Patient Discharge

  1 week

Study Arms (3)

Normal Saline

PLACEBO COMPARATOR

Patients infused with normal saline before and during the surgical procedure as a placebo.

Drug: Normal Saline

Tranexamic acid

EXPERIMENTAL

Patients receive TXA before and during the surgical case.

Drug: Tranexamic Acid

Epsilon Aminocaproic Acid

EXPERIMENTAL

Patients will receive EACA before and during the surgical case.

Drug: Epsilon aminocaproic acid

Interventions

Tranexamic Acid DRUG

For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr.

Also known as: TXA

Tranexamic acid

Normal Saline DRUG

Normal saline of same volume as the intervention group will be given as the intervention group as a loading dose and maintenance dose.

Also known as: Placebo

Normal Saline

Epsilon aminocaproic acid DRUG

For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr.

Also known as: Amicar, EACA

Epsilon Aminocaproic Acid

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine - Department of Orthopaedic Surgery - Spine

New York, New York, 10016, United States

Location

Related Publications (1)

• Verma K, Errico TJ, Vaz KM, Lonner BS. 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. BMC Surg. 2010 Apr 6;10:13. doi: 10.1186/1471-2482-10-13.

  PMID: 20370916 DERIVED

Related Links

• BMC Surgery, April 2010

MeSH Terms

Conditions

Scoliosis

Interventions

Tranexamic Acid; Saline Solution; Aminocaproic Acid

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Aminocaproates; Caproates; Acids, Acyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Thomas Errico (Chief of Spine), Dr. Kushagra Verma (Co-investigator)
• Organization: NYU hospital for Joint Diseases

thomas.errico@nyumc.org; vermak01@gmail.com

212-598-6076

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 13, 2009
• Study Start: December 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 17, 2018
• Results First Posted: December 12, 2017

Record last verified: 2017-12

Locations

US (1)