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

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ClinicalTrials.gov Identifier: NCT00958581
Recruitment Status : Completed
First Posted : August 13, 2009
Results First Posted : December 12, 2017
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Scoliosis
Interventions: Drug: Tranexamic Acid
Drug: Normal Saline
Drug: Epsilon aminocaproic acid

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Consenting completed at PI and co-investigators' private offices, clinic and in preoperative center. Study staff approved by the IRB consent the patients. First patient enrolled on 12/16/2008. Last patient enrolled on 9/17/2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were excluded from the trial after enrollment if their surgery was cancelled.

Reporting Groups
  Description
Epsilon Aminocaproic Acid

Patients will receive EACA before and during the surgical case.

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

Normal Saline

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

Normal Saline :

Tranexamic Acid

Patients receive TXA before and during the surgical case.

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


Participant Flow:   Overall Study
    Epsilon Aminocaproic Acid   Normal Saline   Tranexamic Acid
STARTED   61   61   55 
COMPLETED   61   61   55 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Epsilon Aminocaproic Acid

Patients will receive EACA before and during the surgical case.

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

Normal Saline

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

Normal Saline :

Tranexamic Acid

Patients receive TXA before and during the surgical case.

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

Total Total of all reporting groups

Baseline Measures
   Epsilon Aminocaproic Acid   Normal Saline   Tranexamic Acid   Total 
Overall Participants Analyzed 
[Units: Participants]
 61   61   55   177 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      42  68.9%      47  77.0%      36  65.5%      125  70.6% 
Between 18 and 65 years      15  24.6%      12  19.7%      11  20.0%      38  21.5% 
>=65 years      4   6.6%      2   3.3%      8  14.5%      14   7.9% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      50  82.0%      39  63.9%      45  81.8%      134  75.7% 
Male      11  18.0%      22  36.1%      10  18.2%      43  24.3% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   61   61   55   177 


  Outcome Measures

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

2.  Secondary:   Total Units of Autologous and Allogenic Transfusion (Both Intraoperatively and Postoperatively Until Discharge)   [ Time Frame: 1 week ]

3.  Secondary:   Length of Hospital Stay From Admission Until Patient Discharge   [ Time Frame: 1 week ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Thomas Errico (Chief of Spine), Dr. Kushagra Verma (Co-investigator)
Organization: NYU hospital for Joint Diseases
phone: 212-598-6076
e-mail: thomas.errico@nyumc.org; vermak01@gmail.com


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: January 17, 2018