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

Bloodloss Clinical Trial

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"

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00801190
• Other study ID #: HES
• Status: Not yet recruiting
• Phase: N/A
• First received: December 2, 2008
• Last updated: December 2, 2008
• Start date: December 2008
• Est. completion date: April 2011

Study information

• Verified date: December 2008
• Source: St. Boniface General Hospital Research Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: April 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bloodloss

Intervention

Other:
• HES (130/0.4)
33 ml/kg i.v. during surgery
• Ringer's Lactate
33 ml/kg i.v.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
St. Boniface General Hospital Research Centre	University of Manitoba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Transfusion requirements (RBC and other blood products) both at 24 hours and for duration of hospitalization		first 24 postoperative hours	Yes
Secondary	Re-exploration for bleeding		first 24 postoperative hours	Yes
Secondary	Total intravenous volume administration required in OR and during first 24 hours post-op hours.		first 24 postoperative hours	Yes