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

Tracking Information
First Submitted Date ICMJE	August 25, 2010
First Posted Date ICMJE	August 27, 2010
Last Update Posted Date	November 16, 2010
Study Start Date ICMJE	August 2008
Actual Primary Completion Date	February 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 25, 2010)	PGD scores in the first 72 hours after lung transplantation. [ Time Frame: 72 hours ]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 ]Mortality at 30 days post transplant
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01190059 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 25, 2010)	Extra-corporeal membrane oxygenation use [ Time Frame: 30 days ]If the patient needed to be placed on extra-corporeal membrane oxygenation after transplantation.; Bronchial complications [ Time Frame: 30 days ]To see if there was an increased risk for bronchial complications; Ventilator duration [ Time Frame: 30 days ]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 ]; Hospital length of stay [ Time Frame: 30 days ]Time in the hospital
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation
Official Title ICMJE	Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation
Brief Summary	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.
Detailed Description	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.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
Condition ICMJE	Lung Transplantation
Intervention ICMJE	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.
Study Arms	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™
Publications *	Pierre AF, Sekine Y, Hutcheon MA, Waddell TK, Keshavjee SH. Marginal donor lungs: a reassessment. J Thorac Cardiovasc Surg. 2002 Mar;123(3):421-7; discussion, 427-8.; de Perrot M, Liu M, Waddell TK, Keshavjee S. Ischemia-reperfusion-induced lung injury. Am J Respir Crit Care Med. 2003 Feb 15;167(4):490-511. Review.; Cypel M, Rubacha M, Yeung J, Hirayama S, Torbicki K, Madonik M, Fischer S, Hwang D, Pierre A, Waddell TK, de Perrot M, Liu M, Keshavjee S. Normothermic ex vivo perfusion prevents lung injury compared to extended cold preservation for transplantation. Am J Transplant. 2009 Oct;9(10):2262-9. doi: 10.1111/j.1600-6143.2009.02775.x. Epub 2009 Aug 6.; D.M. Karamanou, H.R. Walden, S. Bean, et al. The Effect of Ex-Vivo Perfusion on the Inflammatory Profile of the Donor Lung. J Heart Lung Transplant 2010:Vol. 29, Issue 2, Supplement, Page S165.; Inci I, Ampollini L, Arni S, Jungraithmayr W, Inci D, Hillinger S, Leskosek B, Vogt P, Weder W. Ex vivo reconditioning of marginal donor lungs injured by acid aspiration. J Heart Lung Transplant. 2008 Nov;27(11):1229-36. doi: 10.1016/j.healun.2008.07.027. Epub 2008 Oct 1.; Steen S, Sjöberg T, Pierre L, Liao Q, Eriksson L, Algotsson L. Transplantation of lungs from a non-heart-beating donor. Lancet. 2001 Mar 17;357(9259):825-9.; Ingemansson R, Eyjolfsson A, Mared L, Pierre L, Algotsson L, Ekmehag B, Gustafsson R, Johnsson P, Koul B, Lindstedt S, Lührs C, Sjöberg T, Steen S. Clinical transplantation of initially rejected donor lungs after reconditioning ex vivo. Ann Thorac Surg. 2009 Jan;87(1):255-60. doi: 10.1016/j.athoracsur.2008.09.049.; Steen S, Ingemansson R, Eriksson L, Pierre L, Algotsson L, Wierup P, Liao Q, Eyjolfsson A, Gustafsson R, Sjöberg T. First human transplantation of a nonacceptable donor lung after reconditioning ex vivo. Ann Thorac Surg. 2007 Jun;83(6):2191-4.; Cypel M, Yeung JC, Liu M, Anraku M, Chen F, Karolak W, Sato M, Laratta J, Azad S, Madonik M, Chow CW, Chaparro C, Hutcheon M, Singer LG, Slutsky AS, Yasufuku K, de Perrot M, Pierre AF, Waddell TK, Keshavjee S. Normothermic ex vivo lung perfusion in clinical lung transplantation. N Engl J Med. 2011 Apr 14;364(15):1431-40. doi: 10.1056/NEJMoa1014597.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: November 12, 2010)	22
Original Estimated Enrollment ICMJE; (submitted: August 25, 2010)	42
Actual Study Completion Date	February 2010
Actual Primary Completion Date	February 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria for donor lung: Recipient to undergo a single or bilateral Lung Transplantation; Last donor PaO2/FiO2 ≤ 300mmHg; Poor oxygenation and/or poor lung compliance is the primary reason for unsuitability; Absence of pneumonia, persistent purulent secretion on bronchoscopy or significant mechanical trauma Exclusion Criteria: Infection; Aspiration; Significant mechanical lung injury - contusion; Infectious diseases : HIV, Hepatitis B and C, HTLV & Syphilis; Malignancy
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Canada
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01190059
Other Study ID Numbers ICMJE	VIT-001-TOR; 139150 ( Other Identifier: Health Canada )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Dr. Shaf Keshavjee, University of Toronto-Toronto General Hospital
Study Sponsor ICMJE	XVIVO Perfusion
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Shaf Keshavjee, MD,MSc,FRCSC University of Toronto-Toronto General Hospital
PRS Account	XVIVO Perfusion
Verification Date	November 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP