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Heparin Dose and Post Operative Bleeding in Cardiopulmonary Bypass Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark Rosin, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01574105
First received: March 6, 2012
Last updated: July 3, 2014
Last verified: July 2014
Results First Received: June 18, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Coronary Artery Disease

  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
Began May 1, 2012 Completed January 15, 2013 Patients identified in preadmission clinic or ward.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Exclusion criteria included: renal failure, liver dysfunction, baseline INR >1.5, clotting factor deficiencies, intra-aortic balloon pump therapy, emergency surgery, pregnancy, ejection fraction less than 50%, age less than 18 years, pulmonary hypertension infectious endocarditis, and history of heparin induced thrombocytopenia.

Reporting Groups
  Description
Heparin Resistant Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
Heparin Sensitive Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.

Participant Flow:   Overall Study
    Heparin Resistant   Heparin Sensitive
STARTED   29   37 
COMPLETED   29   37 
NOT COMPLETED   0   0 



  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
Heparin Resistant Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
Heparin Sensitive Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
Total Total of all reporting groups

Baseline Measures
   Heparin Resistant   Heparin Sensitive   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   37   66 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   11   16   27 
>=65 years   18   21   39 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.4  (9.8)   67.8  (9.4)   67.6  (9.5) 
Gender 
[Units: Participants]
     
Female   3   5   8 
Male   26   32   58 
Region of Enrollment 
[Units: Participants]
     
Canada   29   37   66 


  Outcome Measures
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1.  Primary:   Chest Tube Losses   [ Time Frame: Chest tube losses are recorded from departure from operating room to chest tube removal in the ICU (normally less than 24 hrs) ]

2.  Secondary:   Transfusion Events   [ Time Frame: Data collection begins with patient arrival in the operating room and ends with discharge from the ICU (normally less than 24hrs) ]


  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
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  More Information
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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: Mark Rosin
Organization: Saskatoon Health Region
phone: 306-655-2128
e-mail: mark.rosin@sasktoonhealthregion.ca



Responsible Party: Mark Rosin, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01574105     History of Changes
Other Study ID Numbers: 12-37
Study First Received: March 6, 2012
Results First Received: June 18, 2013
Last Updated: July 3, 2014