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Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)

2014-08-27 03:18:57 | BioPortfolio

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 donor.

Specifically the study aims to:

1. improve resuscitation of potential organ donors.

2. improve organ function in donors.

3. increase organ recovery per donor.

The investigators will randomize 960 subjects to either protocolized resuscitation (n=480) using a consensus-based PPV-guided algorithm or usual care using a 1:1 randomization scheme. The primary outcome is the mean number of organs transplanted per donor. Secondary outcomes include 6mHFS (six-month hospital-free survival) in the recipients, and mean number of organs procured per donor that are suitable for transplantation (intention to transplant). The study is powered to detect a 0.5 organ increase for transplantation per donor.

Study Design

Allocation: Randomized, Control: Uncontrolled, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Conditions

Transplantation

Intervention

Protocolized care

Location

Golden State Donor Services
Sacramento
California
United States
95833

Status

Recruiting

Source

University of Pittsburgh

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:57-0400

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