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Status:

COMPLETED

Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)

Lead Sponsor:

University of Pittsburgh

Collaborating Sponsors:

Health Resources and Services Administration (HRSA)

Conditions:

Transplantation

Eligibility:

All Genders

16+ years

Phase:

NA

Brief Summary

The objective of this study is to determine whether protocol guided resuscitation of brain dead organ donors using Pulse Pressure Variation (PPV) will increase the number of organs transplanted per do...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Donors who were declared brain dead per local hospital brain death criteria.
  • Donors who are deemed suitable for organ donation by the local OPO whether they meet the standard criteria or the extended criteria for donation.
  • Presence of functioning arterial catheter.
  • Exclusion criteria:
  • Inability to obtain informed consent from donor next of kin or legal representative.
  • Donors less than 16 years of age, no maximum age limit.
  • Inability to perform hemodynamic monitoring.
  • Patients on lithium therapy prior to brain death.
  • Known severe aortic regurgitation, intra-cardiac shunts, or on intra-aortic balloon pump.
  • Donors previously enrolled in experimental protocol in which cytokines are the therapeutic targets (e.g. anti-TNF antibodies).
  • Donors receiving chemotherapy or with any disease state (e.g. AIDS) that renders the subject leukopenic (WBC count \< 2).
  • Donors receiving anti-leukocyte drugs (e.g. OKT3) regardless of their WBC counts.
  • Pregnant donors.
  • Donor is on ECMO machine

Exclusion

    Key Trial Info

    Start Date :

    August 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2013

    Estimated Enrollment :

    556 Patients enrolled

    Trial Details

    Trial ID

    NCT00987714

    Start Date

    August 1 2009

    End Date

    March 1 2013

    Last Update

    April 5 2018

    Active Locations (8)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    1

    LifeLink of Georgia

    Norcross, Georgia, United States, 30071

    2

    LifeBanc

    Cleveland, Ohio, United States, 44122

    3

    Lifeline of Ohio

    Columbus, Ohio, United States, 43212

    4

    LifeShare of Oklahoma

    Oklahoma City, Oklahoma, United States, 73116