Bloodloss
Conditions
Keywords
colloid, CABG, cardiopulmonary bypass, bleeding
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 examine, in a prospective randomized double-blind placebo-controlled fashion, the effects of colloid (HES 130/0.4) vs. crystalloid (Ringer's Lactate) on bleeding in patients undergoing cardiopulmonary bypass for cardiac surgery. The primary end point of this trial will be chest tube output at 24 hours. In addition, a range of secondary end points focusing on transfusion parameters, as well as other important end-organ outcomes, will be determined.
Interventions
OTHERHES (130/0.4)
33 ml/kg i.v. during surgery
OTHERRinger's Lactate
33 ml/kg i.v.
Sponsors
University of Manitoba
St. Boniface Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of colloid (HES 130/0.4) administration on blood loss (as determined by chest tube drainage in the first 24 postoperative hours) in patients undergoing cardiac surgery utilizing cardiopulmonary bypass (CPB). | first 24 postoperative hours |
Secondary
| Measure | Time frame |
|---|---|
| Transfusion requirements (RBC and other blood products) both at 24 hours and for duration of hospitalization | first 24 postoperative hours |
| Re-exploration for bleeding | first 24 postoperative hours |
| Total intravenous volume administration required in OR and during first 24 hours post-op hours. | first 24 postoperative hours |
Outcome results
None listed