A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains

Not Applicable

Completed

• Conditions: Spine Deformity
• Interventions: Device: OrthoPAT; Device: Constavac

• Registration Number: NCT02286102
• Lead Sponsor: Hospital for Special Surgery, New York

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2014-11-05
• Study First Submitted QC: 2014-11-05
• Study First Posted: 2014-11-07
• Primary Completion: 2015-08
• Study Completion: 2016-10-17
• Results First Submitted: 2017-03-21
• Results First Submitted QC: 2017-06-26
• Results First Posted: 2017-07-25
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-25
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

The patient is at least 18 years of age The patient is to undergo posterior spine surgery in the thoracic or lumbar region for deformity correction of greater than 6 levels The patient has signed a patient Informed Consent

Exclusion Criteria

The patient is less than 18 years of age The patient has a hematologic disorder of any etiology The patient has received active anticoagulant therapy, including aspirin, Plavix, Heparin, Lovenox or Coumadin within one week of admission The patient has a known active infection or malignancy. The patient has a terminal illness with a life expectancy of less than one year.

The patient requires immuno-suppressive therapy. The patient is undergoing a combined anterior/posterior fusion. The patient has a history of drug or alcohol abuse that may interfere with his/her ability to provide written informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OrthoPAT	OrthoPAT	Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.
Constavac	Constavac	Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.

Primary Outcome Measures

Name	Time	Method
Volume of Allogenic Blood Transfused Postoperatively	48 hours postoperative	The total volume of allogenic blood transfused postoperatively will be measured during the first 48 hours postoperatively while the drains are in place.

Secondary Outcome Measures

Name	Time	Method
Hemoglobin Levels, Post-Op Day 2	2 days postop	Hemoglobin levels will be measured post-operatively day 2
Hemoglobin Levels, Post-Op Day 3	3 days postop	Hemoglobin levels will be measured post-operatively day 3

Trial Locations

Locations (1)

The Hospital for Special Surgery; 🇺🇸 New York, New York, United States