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Topical Application of Tranexamic Acid to Reduce Post-operative Bleeding in Coronary Artery Bypass Surgery

This study has been completed.
Sponsor:
Collaborator:
Saskatoon Health Region
Information provided by (Responsible Party):
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01519245
First received: January 17, 2012
Last updated: May 27, 2013
Last verified: May 2013
Results First Received: December 6, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Coronary Artery Disease
Interventions: Drug: Tranexamic Acid
Drug: normal saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All patients scheduled to undergo elective or urgent CABG at Royal University Hospital between December 1, 2011 and April 30, 2012 were screened for participation. Patients meeting inclusion criteria were approached by a study team member at the time of pre-admission clinic attendance or on the in-patient ward with an invitation to participate.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients meeting inclusion criteria were eligible for study participation. Randomization of consented participants took place by the Clinical Trials Pharmacy on the day of surgery, following confirmation of surgical procedure. The study team could withdraw consented patients prior to randomization and surgery if exclusion criteria were identified.

Reporting Groups
  Description
Trial Drug Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
Placebo Normal saline (70mL)

Participant Flow:   Overall Study
    Trial Drug   Placebo
STARTED   24   20 
Received Pre-pump IV TXA   21 [1]   18 [2] 
Received Post-pump IV TXA   6 [3]   2 [3] 
COMPLETED   23   18 
NOT COMPLETED   1   2 
Met exclusion criteria, not analysed                1                2 
[1] Two patients included in in the final analysis did not receive pre-pump IV TXA.
[2] All patients meeting inclusion criteria received appropriate dosing, as per protocol.
[3] A break in protocol, dosing was given in the operating room at the surgeon's preference.



  Baseline Characteristics
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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
Trial Drug Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
Placebo Normal saline (70mL)
Total Total of all reporting groups

Baseline Measures
   Trial Drug   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   18   41 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   15   11   26 
>=65 years   8   7   15 
Age 
[Units: Years]
Mean (Standard Deviation)
 62  (8.7)   62  (10.4)   62  (9.4) 
Gender 
[Units: Participants]
     
Female   6   6   12 
Male   17   12   29 
Region of Enrollment 
[Units: Participants]
     
Canada   23   18   41 
Mass 
[Units: Kilograms]
Mean (Standard Deviation)
 92.7  (10.5)   91.3  (13.2)   92.2  (11.6) 
Height 
[Units: Meters]
Mean (Standard Deviation)
 1.7  (0.1)   1.7  (0.1)   1.7  (0.1) 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 31.1  (4.2)   31.2  (5.1)   31.1  (4.6) 
Number of Bypasses [1] 
[Units: Number of vessels]
Mean (Standard Deviation)
 4.1  (1.0)   4.3  (1.1)   4.2  (1.1) 
[1] Mean number of vessels bypassed per patient.
Pre-operative Antiplatelet Use [1] 
[Units: Participants]
     
Off 7 days or less   22   18   40 
Off more than 7 days   1   0   1 
[1] Participants receiving Aspirin (ASA) or Plavix (any dose) pre-operatively. Divided in to two categories: discontinuation of antiplatelet agents prior to, or at 7 days before surgery; and more than 7 days before surgery.
Angina [1] 
[Units: Participants]
     
Yes   22   18   40 
No   1   0   1 
[1] Symptomatic angina in weeks leading up to surgery.
History of Myocardial Infarction [1] 
[Units: Participants]
     
Yes   9   9   18 
No   14   9   23 
[1] Diagnosed myocardial infarction at any time in participant's past history.
Stent in situ [1] 
[Units: Participants]
     
Yes   3   4   7 
No   20   14   34 
[1] Any history of participant receiving a coronary vascular stent (bare metal or drug eluding).
Diabetes [1] 
[Units: Participants]
     
Yes   9   7   16 
No   14   11   25 
[1] Diagnosis of Type 1 or 2 diabetes (non-insulin dependent or insulin dependent).
Dyslipidemia 
[Units: Participants]
     
Yes   17   13   30 
No   6   5   11 
Atrial Fibrillation 
[Units: Participants]
     
Yes   0   0   0 
No   23   18   41 
Hypertension 
[Units: Participants]
     
Yes   18   14   32 
No   5   4   9 
Pre-operative Hemoglobin 
[Units: g/L]
Mean (Standard Deviation)
 147  (13)   142  (14)   145  (14) 
Pre-operative platelet count 
[Units: Platelets x 10^9/L]
Mean (Standard Deviation)
 242  (70)   234  (62)   239  (66) 
Pre-operative white blood cell (WBC) count 
[Units: WBC x 10^9/L]
Mean (Standard Deviation)
 7.7  (1.9)   7.9  (3.2)   7.8  (2.5) 
Pre-operative International Normalized Ratio (INR) [1] 
[Units: International Normalized Ratio]
Mean (Standard Deviation)
 1.0  (0.1)   1.0  (0.1)   1.0  (0.1) 
[1] The ratio of a patient's prothrombin time to a normal (control) sample, raised to the power of the International Sensitivity Index (ISI) value for the analytical system used. The calculated value indicates what a patient's PT ratio would be if it was measured using the primary World Health Organization International Reference reagent. The normal range is 0.8-1.2.
Pre-operative Creatinine 
[Units: umol/L]
Mean (Standard Deviation)
 84  (25)   76  (18)   81  (23) 


  Outcome Measures
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1.  Primary:   Total Volume of Blood Loss From Mediastinal Chest Tubes at Time of Removal (Assuming the Total Volume of Loss is Blood).   [ Time Frame: From ICU admission post-operatively to mediastinal chest tube removal (placebo group = 20.6 hours; trial group = 19.8 hours) ]

2.  Primary:   Number of Units of Packed Red Blood Cells (PRBC) Transfused Following Coronary Artery Bypass Graft Surgery   [ Time Frame: From ICU admission to transfer to the Cardiology Ward (placebo group = 24.4 hours; trial group = 24.7 hours) ]

3.  Secondary:   Volume of Blood Loss at 6 Hours   [ Time Frame: 6 hours following admission to the Intensive Care Unit ]

4.  Secondary:   Volume of Blood Loss After 12 Hours   [ Time Frame: 12 hours following admission to the Intensive Care Unit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
  • Small sample size
  • Low-risk CABG patients enrolled only
  • Break in protocol, with pre-pump TXA not given to 2 participants, and post-pump TXA given to 8 participants
  • Short study period, with no long-term follow-up data


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Kelsey Brose, Primary Investigator
Organization: University of Saskatchewan
phone: 306-655-1483
e-mail: kelsey.brose@saskcancer.ca


Publications:

Responsible Party: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01519245     History of Changes
Other Study ID Numbers: 67452-01
Study First Received: January 17, 2012
Results First Received: December 6, 2012
Last Updated: May 27, 2013
Health Authority: Canada: Health Canada