Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-01-02 @ 9:33 AM
Study NCT ID:
NCT02329158
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
2014-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Disinvestment in Hydroxyl-ethyl Starches (HES) for Cardiac Surgery
Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Organization:
Study Overview
Official Title:
Clinical Impact of Disinvestment in Hydroxyl-ethyl Starches (HES) for Patients Undergoing Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
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:
The purpose of this study is to determine whether disinvestment in hydroxyl-ethyl starches (HES) for patients undergoing cardiac surgery was safe and effective.
Detailed Description:
Fluid replacement therapy is administered to patients requiring volume resuscitation following significant blood loss, or for maintenance fluid requirements. Severe blood loss can lead to anemia, reduced oxygen carrying capacity, and organ failure. Options for fluid replacement include red blood cell transfusion, colloids such as hydroxyethyl starches (HES), albumin, and gelatin as well as crystalloids such as normal saline and Ringer's lactate. Until recently, use of HES at the London hospitals and other major health sciences centers was concentrated in cardiac surgery patients and non-critically ill perioperative patients. In April 2013, the London Health Sciences Centre (LHSC) opted to discontinue the use of HES altogether, based on evidence suggesting that HES may be harmful compared to alternative fluid therapies.
The decision to disinvest in HES became effective on April 2, 2013. The hospitals no longer purchased HES, and clinicians used alternative fluids for volume resuscitation. Alternatives available at the hospitals included Ringer's lactate, normal saline, and albumin. All HES product was removed from patient care areas.
The investigators will perform a before/after analysis of the impact of HES disinvestment using a retrospective observational cohort study design, employing data obtained from administrative and clinical databases. Exposure to HES before disinvestment will be assumed to be 100% of cardiac surgical patients, and, after a washout period surrounding the time of disinvestment, exposure to HES will be assumed to be 0% after disinvestment.
The study population will be defined retrospectively in terms of the intervention received and the time period of the intervention.
The decision to disinvest in HES became effective on April 2, 2013. The hospitals no longer purchased HES, and clinicians used alternative fluids for volume resuscitation. Alternatives available at the hospitals included Ringer's lactate, normal saline, and albumin. All HES product was removed from patient care areas.
The investigators will perform a before/after analysis of the impact of HES disinvestment using a retrospective observational cohort study design, employing data obtained from administrative and clinical databases. Exposure to HES before disinvestment will be assumed to be 100% of cardiac surgical patients, and, after a washout period surrounding the time of disinvestment, exposure to HES will be assumed to be 0% after disinvestment.
The study population will be defined retrospectively in terms of the intervention received and the time period of the intervention.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: