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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by St. Boniface General Hospital Research Centre.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University of Manitoba
Information provided by:
St. Boniface General Hospital Research Centre
ClinicalTrials.gov Identifier:
NCT00801190
First received: December 2, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Bloodloss
Other: HES (130/0.4)
Other: Ringer's Lactate

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

Resource links provided by NLM:


Further study details as provided by St. Boniface General Hospital Research Centre:

Primary Outcome Measures:
  • 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). [ Time Frame: first 24 postoperative hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Transfusion requirements (RBC and other blood products) both at 24 hours and for duration of hospitalization [ Time Frame: first 24 postoperative hours ] [ Designated as safety issue: Yes ]
  • Re-exploration for bleeding [ Time Frame: first 24 postoperative hours ] [ Designated as safety issue: Yes ]
  • Total intravenous volume administration required in OR and during first 24 hours post-op hours. [ Time Frame: first 24 postoperative hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: December 2008
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HES (130/0.4)
33 ml/kg i.v. HES (130/0.4)
Other: HES (130/0.4)
33 ml/kg i.v. during surgery
Other Name: Voluven
Placebo Comparator: Ringer's Lactate
33 ml/kg i.v. Rigner's Lactate
Other: Ringer's Lactate
33 ml/kg i.v.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dr. Hilary Grocott, Saint Boniface general Hospital /Universit of Manitoba
ClinicalTrials.gov Identifier: NCT00801190     History of Changes
Other Study ID Numbers: HES
Study First Received: December 2, 2008
Last Updated: December 2, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Boniface General Hospital Research Centre:
colloid
CABG
cardiopulmonary bypass
bleeding

ClinicalTrials.gov processed this record on September 30, 2014