Status:
UNKNOWN
This Study Will Compare the Effect of Starch Containing to Non-Starch Containing Intravenous Fluid on Blood Loss During Coronary Artery Bypass Graft Surgery
Lead Sponsor:
St. Boniface Hospital
Collaborating Sponsors:
University of Manitoba
Conditions:
Bloodloss
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The overall aim of this study is to determine if there is a bleeding risk associated with the use of starch-containing fluids during cardiac surgery. The specific purpose of this study will be to exam...
Eligibility Criteria
Inclusion
- Male or female, 18 - 85 years of age, inclusive
- Willing and able to provide informed consent
- Elective primary coronary artery bypass graft (CABG) requiring cardiopulmonary bypass, isolated valve repair, or isolated valve replacement surgery, or combined single valve plus CABG.
Exclusion
- Emergency surgery (\< 12 hours from determination of need for surgery)
- Significant other concomitant surgery (including, but not limited to, multiple valve replacement, CEA, planned circulatory arrest, etc.)
- LVEF \< 25 %
- Preoperative use of inotropes
- Preoperative intraoartic balloon pump (IABP)
- Renal dysfunction: Serum Creatinine \>140 μmol/L
- Hepatic dysfunction: AST or ALT \> 2.5 x upper limit normal; or otherwise known hepatic disease
- Preoperative Hb \< 100 g/L
- Platelet count \<100,000/mm3,
- INR \> 1.3; PTT \> 38 sec (with the exception of patients receiving preoperative heparin)
- History or family history of bleeding disorder
- Patients currently receiving: Eptifibatide (Integrilin) within 12 hours Danaparoid, Enoxaparin sodium (Lovenox) or other low molecular weight heparin within 24 hours ,Clopidogrel (Plavix) within 7 days ,Warfarin (Coumadin) within 5 days, Ticlopidine (Ticlid) within 7 day
- Dermatological syndromes with pruritus
- Planned neuraxial anesthetic technique
- Receipt of an investigational drug or device, within 30 days prior to study treatment
- Pregnant or breast feeding females
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00801190
Start Date
December 1 2008
End Date
April 1 2011
Last Update
December 3 2008
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