NCT02286102

A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains

A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains for Adults Undergoing Multilevel Spine Surgery for Deformity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Spine Deformity

Interventions

Type	Name	Description
DEVICE	OrthoPAT	OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively
DEVICE	Constavac	Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-08-01
• Completion: 2016-10-17
• First posted: 2014-11-07
• Last updated: 2019-10-29
• Results posted: 2017-07-25

Locations

1 site across 1 country: United States