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

Lung Transplantation Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190059
• Other study ID #: VIT-001-TOR
• Secondary ID: 139150
• Status: Completed
• Phase: Phase 1
• First received: August 25, 2010
• Last updated: November 12, 2010
• Start date: August 2008
• Est. completion date: February 2010

Study information

• Verified date: November 2010
• Source: XVIVO Perfusion
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
XVIVO Perfusion

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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

Outcome

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