Tranexamic Acid (TXA) Versus Epsilon Aminocaproic Acid (EACA) Versus Placebo for Spine Surgery
|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.|
|ClinicalTrials.gov Identifier: NCT00958581|
Recruitment Status : Completed
First Posted : August 13, 2009
Results First Posted : December 12, 2017
Last Update Posted : January 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Scoliosis||Drug: Tranexamic Acid Drug: Normal Saline Drug: Epsilon aminocaproic acid||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||177 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
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
- Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge) [ Time Frame: 1 Week ]
- 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 ]
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
|United States, New York|
|New York University School of Medicine - Department of Orthopaedic Surgery - Spine|
|New York, New York, United States, 10016|
|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|