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The lungs retrieved from the brain dead multi organ donor will be placed in a lab . They will be connected to a ventilator and preservative solution will be circulated through it . Blood will be added to the fluid depending on the group to which the lungs are allocated and its effects on lung function will be seen
The lungs of a brain dead multi organ donor will be retrieved according to standard protocol. Once a decision is made not to transplant the lungs either because of not satisfying ideal criteria or in the absence of a potential recipient they will be included in the study.They will be ventilated optimally and connected to a cardiopulmonary bypass machine for circulating preservative solution through it . Red blood cells will be added to the solution either initially or later depending on the group to which it is allocated .Monitoring of mechanical and gas exchange function and pathological examination of the lungs will be performed at various time points to observe the effect of red blood cells. The lungs will be properly discarded at the end of the procedure and will not be used for transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acellular first | Experimental | Lung preservative solution without red blood cells will be used for perfusion in the initial 2 hours followed by addition of red blood cells for the next two hours |
|
| Cellular first | Experimental | Lung preservative solution will contain red blood cells for the first two hours followed by acellular perfusate for the next two hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red blood cells | Other | Packed red blood cells to final hematocrit of 14% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compliance | Measured from the airway pressure on ventilator | From beginning of perfusion to 4 hours after that |
| Measure | Description | Time Frame |
|---|---|---|
| Partial pressure to Inspired oxygen concentration ratio | Ratio of partial pressure of oxygen in perfusate to fraction of inspired oxygen | From beginning of perfusion to 4 hours after that |
| Pulmonary vascular resistance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rajarajan Ganesan, MD | Contact | +919815930510 | raja2n@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Goverdhan D Puri, MD, PhD | Post Graduate Institute of Medical Education and Research, Chandigarh | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Postgraduate Institute of Medical Education and Research | Recruiting | Chandigarh | Chandigarh | 160012 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21488765 | Background | 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. | |
| 22975103 |
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| ID | Term |
|---|---|
| D004906 | Erythrocyte Count |
| ID | Term |
|---|---|
| D001772 | Blood Cell Count |
| D002452 | Cell Count |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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Calculated from measured pulmonary artery pressure and pump flow
| From beginning of perfusion to 4 hours after that |
| Lung injury score | By pathological examination | From beginning of perfusion to 4 hours after that |
| Yeung JC, Cypel M, Machuca TN, Koike T, Cook DJ, Bonato R, Chen M, Sato M, Waddell TK, Liu M, Slutsky AS, Keshavjee S. Physiologic assessment of the ex vivo donor lung for transplantation. J Heart Lung Transplant. 2012 Oct;31(10):1120-6. doi: 10.1016/j.healun.2012.08.016. |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |