Back to resultsA Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains
Primary Purpose
Spine Deformity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OrthoPAT
Constavac
Sponsored by
About this trial
This is an interventional treatment trial for Spine Deformity
Eligibility Criteria
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.
Sites / Locations
- The Hospital for Special Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
OrthoPAT
Constavac
Arm Description
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.
Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Hemoglobin Levels, Post-Op Day 3
Hemoglobin levels will be measured post-operatively day 3
Hemoglobin Levels, Post-Op Day 2
Hemoglobin levels will be measured post-operatively day 2
Full Information
NCT ID
NCT02286102
First Posted
November 5, 2014
Last Updated
October 25, 2019
Sponsor
Hospital for Special Surgery, New York
1. Study Identification
Unique Protocol Identification Number
NCT02286102
Brief Title
A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains
Official Title
A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains for Adults Undergoing Multilevel Spine Surgery for Deformity
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2011 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
October 17, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Deformity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OrthoPAT
Arm Type
Experimental
Arm Description
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.
Arm Title
Constavac
Arm Type
Active Comparator
Arm Description
Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.
Intervention Type
Device
Intervention Name(s)
OrthoPAT
Intervention Description
OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively
Intervention Type
Device
Intervention Name(s)
Constavac
Intervention Description
Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively
Primary Outcome Measure Information:
Title
Volume of Allogenic Blood Transfused Postoperatively
Description
The total volume of allogenic blood transfused postoperatively will be measured during the first 48 hours postoperatively while the drains are in place.
Time Frame
48 hours postoperative
Secondary Outcome Measure Information:
Title
Hemoglobin Levels, Post-Op Day 3
Description
Hemoglobin levels will be measured post-operatively day 3
Time Frame
3 days postop
Title
Hemoglobin Levels, Post-Op Day 2
Description
Hemoglobin levels will be measured post-operatively day 2
Time Frame
2 days postop
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Ross, RN
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Han Jo Kim, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains
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