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A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains

NCT02286102 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-10-29

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Tom Ross, RN · Hospital for Special Surgery, New York

  • Han Jo Kim, MD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-08-31
Completion
2016-10-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02286102 on ClinicalTrials.gov