International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation (INSPIRE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01630434 |
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Recruitment Status :
Completed
First Posted : June 28, 2012
Results First Posted : July 7, 2022
Last Update Posted : July 7, 2022
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Sponsor:
TransMedics
Information provided by (Responsible Party):
TransMedics
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Lung Preservation |
| Interventions |
Device: OCS Lung Device: Cold flush and storage |
| Enrollment | 320 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | OCS Lung (Treatment Group) | Cold Flush and Storage (Control Group) |
|---|---|---|
 Arm/Group Description |
The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group). |
Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage |
| Period Title: Overall Study | ||
| Started [1] | 151 | 169 |
| Safety Population | 150 | 169 |
| Per Protocol Population | 141 | 165 |
| Completed [2] | 121 | 139 |
| Not Completed | 30 | 30 |
| Reason Not Completed | ||
| Donor lungs turned down | 1 | 0 |
| Protocol Violation | 9 | 4 |
| Death | 20 | 26 |
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[1]
Intention-to-treat population
[2]
Number of per protocol subjects that completed 24-month follow-up
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Baseline Characteristics
| Arm/Group Title | OCS Lung (Treatment Group) | Cold Flush and Storage (Control Group) | Total | |
|---|---|---|---|---|
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Arm/Group Description |
The OCS Lung, which is a portable, integrated platform designed to maintain adult donor lungs in a normothermic state through continuous normothermic perfusion and ventilation, will be used to preserve and transport donor lungs. OCS Lung: OCS Lung will be used to preserve the donor lungs (Treatment Group). |
Donor lungs will be preserved using cold flush and storage (control group) Cold flush and storage: Donor lungs will preserved using standard cold flush and storage |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 151 | 169 | 320 | |
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Baseline Analysis Population Description |
Intent-to-treat Population
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Age, Continuous
[1] Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 151 participants | 169 participants | 320 participants | |
| 42.2 (14.4) | 40.2 (13.7) | 41.1 (14.1) | ||
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[1]
Measure Description: Donor Age (years)
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Age, Continuous
[1] Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 151 participants | 169 participants | 320 participants | |
| 50.4 (13.1) | 50.0 (13.6) | 50.2 (13.3) | ||
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[1]
Measure Description: Recipient Age (years)
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Sex: Female, Male
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 151 participants | 169 participants | 320 participants | |
| Female |
72 47.7%
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67 39.6%
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139 43.4%
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| Male |
79 52.3%
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102 60.4%
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181 56.6%
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[1]
Measure Description: Donor Sex (Male/Female)
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Sex: Female, Male
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 151 participants | 169 participants | 320 participants | |
| Female |
74 49.0%
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63 37.3%
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137 42.8%
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| Male |
77 51.0%
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106 62.7%
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183 57.2%
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[1]
Measure Description: Recipient Sex (Male/Female)
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Donor Smoking History in Past 6 Months
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 151 participants | 169 participants | 320 participants | |
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27 17.9%
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27 16.0%
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54 16.9%
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Final PaO2:FiO2 (mm Hg)
Mean (Standard Deviation) Unit of measure: Mm Hg |
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| Number Analyzed | 151 participants | 169 participants | 320 participants | |
| 438.5 (80.0) | 431.7 (73.8) | 434.9 (76.7) | ||
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Recipient Transplant Indication
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 151 participants | 169 participants | 320 participants | |
| COPD |
46 30.5%
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52 30.8%
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98 30.6%
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| Pulmonary Fibrosis |
49 32.5%
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57 33.7%
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106 33.1%
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| Cystic Fibrosis |
31 20.5%
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40 23.7%
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71 22.2%
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| Idiopathic Pulmonary Hypertension |
13 8.6%
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6 3.6%
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19 5.9%
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| Sarcoidosis |
4 2.6%
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8 4.7%
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12 3.8%
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| Other |
8 5.3%
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6 3.6%
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14 4.4%
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Recipient Lung Allocation Score
[1] Mean (Standard Deviation) Unit of measure: Score on a scale |
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| Number Analyzed | 151 participants | 169 participants | 320 participants | |
| 50.8 (20.9) | 47.9 (18.7) | 49.3 (19.8) | ||
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[1]
Measure Description: Recipient lung allocation score (LAS) is the value that determines a recipient's urgency on the waitlist. This score is assigned on a scale of 0 to 100, 0 being the least urgent and 100 being the most urgent recipient.
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Recipient BMI
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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| Number Analyzed | 151 participants | 169 participants | 320 participants | |
| 23.2 (4.6) | 23.0 (4.1) | 23.1 (4.3) | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Site shall have right to publish results. To balance this right with TransMedics' (TM) proprietary interests, site will submit manuscripts intended for publication for TM's review at least 60d prior to submission date. TM will complete its review within 60d of receipt. TM may request that site delete from its manuscripts any reference to TM confidential information and site shall promptly comply with such request. After 60d period, site will have right to publish manuscript, as amended by TM.
Results Point of Contact
| Name/Title: | VP, Clinical Affairs |
| Organization: | TransMedics, Inc. |
| Phone: | 978.552.0900 |
| EMail: | ldamme@transmedics.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | TransMedics |
| ClinicalTrials.gov Identifier: | NCT01630434 |
| Other Study ID Numbers: |
OCS-LUN-03-2010 |
| First Submitted: | June 25, 2012 |
| First Posted: | June 28, 2012 |
| Results First Submitted: | April 6, 2022 |
| Results First Posted: | July 7, 2022 |
| Last Update Posted: | July 7, 2022 |