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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03276403 |
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Date of registration:
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06/09/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Primary Graft Dysfunction Score in Lung Transplantation
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Scientific title:
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?Finding New Criteria for a Revised Primary Graft Dysfunction Score in Lung Transplantation - a Pilot Study |
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Date of first enrolment:
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November 1, 2016 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03276403 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Austria
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Canada
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Contacts
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Name:
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Konrad Hoetzenecker, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of Vienna |
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Name:
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Konrad Hoetzenecker, MD, PhD |
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Address:
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Telephone:
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0043140400 |
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Email:
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konrad.hoetzenecker@meduniwien.ac.at |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Double lung transplantation for primary pulmonary hypertension (PPH), Fibrosis, cystic
fibrosis (CF), Emphysema
- No restrictions regarding donor lungs (marginal donors, EVLP possible)
- No restrictions regarding size reduction (anatomic wedge resections, three lobar,
lobar transplantations)
Exclusion Criteria:
- Single-lung transplantation
- Heart-lung transplantation
- Re-transplantation
- Patients with bridge-to-transplantation with a mechanical assist device
(extra-corporal membrane oxygenation (v/v, v/a), PA/LA Novalung, ILAactive, ILA)
- Clinical situations leading to inaccurate PiCCO measurements e.g. intracardiac shunts,
significant tricuspid regurgitation, cooling
- No access to the femoral artery possible
- Severe postoperative hemorrhage, which leads to hematothorax and makes revision
surgery necessary
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lung Transplant; Complications
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Intervention(s)
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Device: PiCCO Catheter
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Primary Outcome(s)
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Primary graft dysfunction
[Time Frame: 72 hours after transplantation]
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Secondary ID(s)
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1618/2016
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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