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

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.

Study Overview

• Status: Completed
• Conditions: Spine Deformity
• Intervention / Treatment: Device: OrthoPAT; Device: Constavac

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • The Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: OrthoPAT; OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively
Active Comparator: Constavac; Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.	Device: Constavac; Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin Levels, Post-Op Day 3	Hemoglobin levels will be measured post-operatively day 3	3 days postop
Hemoglobin Levels, Post-Op Day 2	Hemoglobin levels will be measured post-operatively day 2	2 days postop

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Study Director: Tom Ross, RN, Hospital for Special Surgery, New York; Principal Investigator: Han Jo Kim, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): October 17, 2016

Study Registration Dates

• First Submitted: November 5, 2014
• First Submitted That Met QC Criteria: November 5, 2014
• First Posted (Estimate): November 7, 2014

Study Record Updates

• Last Update Posted (Actual): October 29, 2019
• Last Update Submitted That Met QC Criteria: October 25, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 2014-363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO