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

NCT ID: NCT00801190

Last Updated: 2008-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bloodloss

Keywords

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colloid CABG cardiopulmonary bypass bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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HES (130/0.4)

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

Group Type ACTIVE_COMPARATOR

HES (130/0.4)

Intervention Type OTHER

33 ml/kg i.v. during surgery

Ringer's Lactate

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

Group Type PLACEBO_COMPARATOR

Ringer's Lactate

Intervention Type OTHER

33 ml/kg i.v.

Interventions

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HES (130/0.4)

33 ml/kg i.v. during surgery

Intervention Type OTHER

Ringer's Lactate

33 ml/kg i.v.

Intervention Type OTHER

Other Intervention Names

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Voluven

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role collaborator

St. Boniface Hospital

OTHER

Sponsor Role lead

Responsible Party

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Saint Boniface general Hospital /Universit of Manitoba

Other Identifiers

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HES

Identifier Type: -

Identifier Source: org_study_id