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