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

NCT00801190 | Unknown DMC

• 1 other identifier: HES
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bloodloss

Keywords

colloid; CABG; cardiopulmonary bypass; bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

HES (130/0.4)

ACTIVE COMPARATOR

33 ml/kg i.v. HES (130/0.4)

Other: HES (130/0.4)

Ringer's Lactate

PLACEBO COMPARATOR

33 ml/kg i.v. Rigner's Lactate

Other: Ringer's Lactate

Interventions

HES (130/0.4) OTHER

33 ml/kg i.v. during surgery

Also known as: Voluven

HES (130/0.4)

Ringer's Lactate OTHER

33 ml/kg i.v.

Ringer's Lactate

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Boniface Hospital: lead
• University of Manitoba: collaborator

MeSH Terms

Conditions

Hemorrhage

Interventions

Hydroxyethyl Starch Derivatives; HES 130-0.4; Ringer's Lactate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 3, 2008
• Study Start: December 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2011
• Last Updated: December 3, 2008

Record last verified: 2008-12