Lung Transplantation Clinical Trial
— HELPOfficial title:
Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation
Verified date | November 2010 |
Source | XVIVO Perfusion |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | February 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Canada | Toronto General Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
XVIVO Perfusion |
Canada,
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. — View Citation
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.
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PGD scores in the first 72 hours after lung transplantation. | 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. | 72 hours | Yes |
Primary | 30 day Mortality | Mortality at 30 days post transplant | 30 days | No |
Secondary | Extra-corporeal membrane oxygenation use | If the patient needed to be placed on extra-corporeal membrane oxygenation after transplantation. | 30 days | No |
Secondary | Bronchial complications | To see if there was an increased risk for bronchial complications | 30 days | Yes |
Secondary | Ventilator duration | How long was the patient on the ventilator after lung transplantation and was there an increased time on ventilator for the patient after EVLP. | 30 days | No |
Secondary | Intensive Care Unit length of stay | 30 days | No | |
Secondary | Hospital length of stay | Time in the hospital | 30 days | No |
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