A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains

NCT02286102 | Completed Results

• 1 other identifier: 2014-363
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Deformity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Hemoglobin Levels, Post-Op Day 3

  3 days postop

• Hemoglobin Levels, Post-Op Day 2

  2 days postop

Study Arms (2)

OrthoPAT

EXPERIMENTAL

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

Constavac

ACTIVE COMPARATOR

Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.

Device: Constavac

Interventions

OrthoPAT DEVICE

OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively

OrthoPAT

Constavac DEVICE

Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively

Constavac

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

The Hospital for Special Surgery

New York, New York, 10021, United States

Location

Results Point of Contact

• Title: Oheneba Boachie-Adjei, MD
• Organization: Hospital for Special Surgery

rosst@hss.edu

212 606-1723

Study Officials

• Tom Ross, RN

  Hospital for Special Surgery, New York

  STUDY DIRECTOR

• Han Jo Kim, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 7, 2014
• Study Start: January 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: October 17, 2016
• Last Updated: October 29, 2019
• Results First Posted: July 25, 2017

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)