Tranexamic Acid in Off-pump Coronary Surgery (TAOPCAB)

This study has been completed.
Sponsor:
Information provided by:
Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier:
NCT01064167
First received: February 4, 2010
Last updated: January 11, 2011
Last verified: February 2010
Results First Received: August 30, 2010  
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: Treatment
Condition: Off Pump Coronary Artery Bypass Surgery
Intervention: Drug: Tranexamic Acid

  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
From February 2009 to December 2009, 378 consecutive patients in Fuwai hospital scheduled for elective OPCAB were enrolled in the study. 118 patients were excluded for randomizatin because not meeting inclusion criteria(n=29), Refused to participate(n=81),and surgery cancelled(n=8).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 260 patients randomized, 130 were allocated to each group. 14 patients in tranexamic acid group and 15 in placebo group were withdrawn from the study for convert to on-pump surgery in course of surgery.

Reporting Groups
  Description
Tranexamic Acid Group Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
Control Group The placebo consisted of an equivalent volume of saline solution.

Participant Flow:   Overall Study
    Tranexamic Acid Group     Control Group  
STARTED     130     130  
COMPLETED     116     115  
NOT COMPLETED     14     15  
Protocol Violation                 14                 15  



  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
Tranexamic Acid Group Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
Control Group The placebo consisted of an equivalent volume of saline solution.
Total Total of all reporting groups

Baseline Measures
    Tranexamic Acid Group     Control Group     Total  
Number of Participants  
[units: participants]
  130     130     260  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     86     89     175  
>=65 years     44     41     85  
Age  
[units: years]
Mean ± Standard Deviation
  60.5  ± 8.0     60  ± 8.5     60.4  ± 8.5  
Gender  
[units: participants]
     
Female     26     16     42  
Male     104     114     218  
Region of Enrollment  
[units: participants]
     
China     130     130     260  



  Outcome Measures
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1.  Primary:   Number of Patients Required Allogenic Red Blood Cells Transfusion   [ Time Frame: 1month postoperative ]

2.  Secondary:   Postoperative Chest Tube Drainage   [ Time Frame: 24h postoperative ]


  Serious Adverse Events


  Other Adverse Events


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


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.  


Results Point of Contact:  
Name/Title: Guyan Wang
Organization: Cardiovascular Institute & Fuwai Hospital
phone: 86-10-88398377
e-mail: guyanwang2006@163.com


No publications provided by Cardiovascular Institute & Fuwai Hospital

Publications automatically indexed to this study:

Responsible Party: Lihuan Li/Professor & Chief, Dep. of anesthesiology, Cardiovascular Institute and Fuwai Hospital, CAMS and PUMC
ClinicalTrials.gov Identifier: NCT01064167     History of Changes
Other Study ID Numbers: FWMZ013
Study First Received: February 4, 2010
Results First Received: August 30, 2010
Last Updated: January 11, 2011
Health Authority: China: Food and Drug Administration