This Study Will Compare the Effect of Starch Containing to Non-Starch Containing Intravenous Fluid on Blood Loss During Coronary Artery Bypass Graft Surgery

St. Boniface Hospital

Status

Unknown

Conditions

Bloodloss

Treatments

Other: Ringer's Lactate

Other: HES (130/0.4)

Study type

Interventional

Funder types

Other

Identifiers

NCT00801190

HES

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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