Clinical trial NCT00801190: This Study Will Compare the Effect of Starch Containing to Non-Starch Containing Intravenous Fluid on Blood Loss During Coronary Artery Bypass Graft Surgery
Official title: A Prospective Randomized Double-Blind Placebo-Controlled Trial of the Effects of Colloid (HES 130/0.4) Versus Crystalloid (Ringer's Lactate) on Bleeding in Patients Undergoing Cardiopulmonary Bypass for Primary CABG, Single Valve Repair/Replacement, or Combined Single Valve/CABG Surgery"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bloodloss
Keywords: colloid
CABG
cardiopulmonary bypass
bleeding
Lead sponsor: St. Boniface Hospital
Sponsor class: OTHER
Collaborators: name: University of Manitoba
First posted: 2008-12-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: first 24 postoperative hours
Secondary outcomes:
measure: Transfusion requirements (RBC and other blood products) both at 24 hours and for duration of hospitalization
timeFrame: first 24 postoperative hours
measure: Re-exploration for bleeding
timeFrame: first 24 postoperative hours
measure: Total intravenous volume administration required in OR and during first 24 hours post-op hours.
timeFrame: first 24 postoperative hours
Other outcomes:
Locations:
Study officials:
References: