Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation (HELP)

This study has been completed.
Sponsor:
Information provided by:
XVIVO Perfusion
ClinicalTrials.gov Identifier:
NCT01190059
First received: August 25, 2010
Last updated: November 12, 2010
Last verified: November 2010

August 25, 2010
November 12, 2010
August 2008
February 2010   (final data collection date for primary outcome measure)
  • PGD scores in the first 72 hours after lung transplantation. [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Immediate lung function is one of the key factors in determining the impact of donor lung quality, therefore the PGD score within 72 hrs was selected as the primary endpoint.
  • 30 day Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Mortality at 30 days post transplant
Same as current
Complete list of historical versions of study NCT01190059 on ClinicalTrials.gov Archive Site
  • Extra-corporeal membrane oxygenation use [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    If the patient needed to be placed on extra-corporeal membrane oxygenation after transplantation.
  • Bronchial complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    To see if there was an increased risk for bronchial complications
  • Ventilator duration [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    How long was the patient on the ventilator after lung transplantation and was there an increased time on ventilator for the patient after EVLP.
  • Intensive Care Unit length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Time in the hospital
Same as current
Not Provided
Not Provided
 
Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation
Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation

The use of ex vivo lung perfusion (EVLP) will allow for a secondary evaluation technique for donor lungs that fail to meet standard acceptability criteria. This advanced assessment might lead to increased utilization rates of donor lungs and improved outcomes after lung transplantation.

Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques.

These lungs will be brought to the study transplant center to be re-assessed by the transplant team. The lungs will be physiologically assessed during ex vivo perfusion with Steen Solution. Perfusion of these lungs will be performed using Steen solution with the addition of methylprednisolone, heparin and antibiotics. With respect to the decision of lung utilization those organs with a delta pO2 (Δ pO2 = Pulmonary vein pO2 - pulmonary artery pO2) during ex vivo perfusion assessment > 350mmHg, good lung compliance, and a favorable opinion of the transplant surgeon will be considered transplantable. Lungs will be excluded for transplantation: if the Δ pO2 is less than 350mmHg or if they demonstrate >10% deterioration in any of the following functional parameters: pulmonary vascular resistance (PVR), dynamic compliance or airway pressures. Lungs will also be excluded if they are deemed unsuitable based on the clinical judgment of the lung transplant surgeon.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Lung Transplantation
Drug: Ex vivo lung perfusion with Steen Solution™
The circuit is primed with 2,000cc Steen Solution™. At one hour of EVLP, 500 cc of circulated perfusate was removed and replenished with 500 cc of fresh perfusate. After that, 250 cc of perfusate was exchanged every hour.
Experimental: EVLP Group
EVLP Group are those recipient lung transplant patients that received donor lungs that had been placed on the ex vivo lung perfusion system with Steen Solution™ .
Intervention: Drug: Ex vivo lung perfusion with Steen Solution™

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria for donor lung:

  1. Recipient to undergo a single or bilateral Lung Transplantation
  2. Last donor PaO2/FiO2 ≤ 300mmHg
  3. Poor oxygenation and/or poor lung compliance is the primary reason for unsuitability
  4. Absence of pneumonia, persistent purulent secretion on bronchoscopy or significant mechanical trauma

Exclusion Criteria:

  1. Infection
  2. Aspiration
  3. Significant mechanical lung injury - contusion
  4. Infectious diseases : HIV, Hepatitis B and C, HTLV & Syphilis
  5. Malignancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01190059
VIT-001-TOR, 139150
Yes
Dr. Shaf Keshavjee, University of Toronto-Toronto General Hospital
XVIVO Perfusion
Not Provided
Principal Investigator: Shaf Keshavjee, MD,MSc,FRCSC University of Toronto-Toronto General Hospital
XVIVO Perfusion
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP