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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.


Clinical Trial Description

n/a


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00801190
Study type Interventional
Source St. Boniface General Hospital Research Centre
Contact
Status Not yet recruiting
Phase N/A
Start date December 2008
Completion date April 2011

See also
  Status Clinical Trial Phase
Unknown status NCT01444508 - Effect of Colloid Versus Crystalloid on Coagulation Phase 4
Completed NCT00816023 - A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume Phase 2
Completed NCT00888940 - Outcomes and Safety Trial Investigating Ecallantide's Effect on Reducing Surgical Blood Loss Volume in Subjects at High Risk of Bleeding Exposed to Cardio-pulmonary Bypass During Cardiac Surgery Phase 2
Completed NCT00777166 - Cardiac Effects of Oxytocin Administrated During Cesarean Section, Signs of Myocardial Ischemia Phase 4