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Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)
NCT00987714 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- PROCEDURE Protocolized care
Study Locations (8)
Ohio
- LifeBanc — Cleveland
- Lifeline of Ohio — Columbus
Georgia
- LifeLink of Georgia — Norcross
Oklahoma
- LifeShare of Oklahoma — Oklahoma City
Pennsylvania
- Center for Organ Recovey and Education — Pittsburgh
Tennessee
- Tennessee Donor Services — Knoxville
Texas
- Southwest Transplant Alliance-Dallas — Dallas
Washington
- Lifecenter North West — Bellevue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 556 participants |
| Start Date | 2009-08 |
| Est. Completion | 2013-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00987714
The ClinicalTrials.gov registry entry for NCT00987714 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 556 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,082 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Transplantation appearing as the primary indexed condition, and to 1 intervention — of which Protocolized care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00987714 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Ohio, Georgia, Oklahoma. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00987714 about?
NCT00987714 is a clinical study titled "Monitoring Organ Donors to Increase Transplantation Results (MOnIToR)". 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. improv...
What is the current status of trial NCT00987714?
This trial is currently completed. It is a NA study. The enrollment target is 556 participants. The study started on 2009-08. Estimated completion is 2013-03.
What conditions does trial NCT00987714 study?
This clinical trial studies the following conditions: Transplantation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00987714?
The interventions under investigation include: Protocolized care (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00987714?
This trial is sponsored by University of Pittsburgh, which has 1,082 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00987714 being conducted?
This trial has 8 study locations across Georgia, Ohio, Oklahoma, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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