Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-26 @ 6:52 AM
Study NCT ID:
NCT02286102
Status:
COMPLETED
Last Update Posted:
2019-10-29
First Post:
2014-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains
Sponsor:
Hospital for Special Surgery, New York
Organization:
Study Overview
Official Title:
A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains for Adults Undergoing Multilevel Spine Surgery for Deformity
Status:
COMPLETED
Status Verified Date:
2019-10
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 examination of the ability of the OrthoPAT® blood collection device to decrease the transfusion rate and volume of adults undergoing posterior spine surgery for deformity correction of 6 levels or more.
Detailed Description:
The purpose of this study is to investigate the use of postoperative drains with blood salvage capabilities to determine if they decrease both the volume and rate of allogenic blood transfusion in adult patients undergoing multilevel spine surgery for deformity. In addition, the ability of these drains to decrease the complications that are associated with allogenic blood exposure (postoperative infection, volume overload and transfusion reactions) will also be evaluated.
Study Oversight
Has Oversight DMC:
False
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?: