Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182377
Status:
UNKNOWN
Last Update Posted:
2007-09-20
First Post:
2005-09-13
Brief Title:
Pentastarch Use in Cardiac Surgery
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
A Randomized Prospective Blinded Clinical Trial to Evaluate the Efficacy and Safety of Pentastarch Use in Patients Undergoing Coronary Artery Bypass Surgery or Valve Replacement Surgery Using Cardiopulmonary Bypass Circuits
Status:
UNKNOWN
Status Verified Date:
2004-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients undergoing cardiac surgery with cardiopulmonary bypass require significant fluid administration Fluids are used routinely to replace blood lost during and after surgery Significant amounts of fluid are also used to prime the tubing and components of the cardiopulmonary bypass pump before and during its use The use of Pentaspan - a synthetic pentastarch - was started because of the restriction of use for blood and blood products particularly albumin Pentaspan is usually used after surgery in the Intensive Care Unit ICU The impact of the use of pentastarch on coagulation fluid balance and bleeding are very limited This study will methodically evaluate the impact of using increasingly greater amounts of pentastarch during surgery on an open heart surgery patients recovery in particular - is there more bleeding does hisher blood clot as well and how much fluid overall is used and excreted
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None