An observational study in Primary Graft Dysfunction, sponsored by University Hospital, Strasbourg, France. Status unknown at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-02.
Sponsored by University Hospital, Strasbourg, France · Observational
Primary graft dysfunction (PGD or lung reperfusion edema) complicates 10 to 20% of lung transplantations and leads to severe early and late postoperative complications. Its pathophysiology remains unclear but may involve graft ischemia-reperfusion, increased vascular permeability, pneumocyte dysfunction and finally alveolar flooding that impair gas exchange and blood oxygenation.Its substrate, namely extravascular lung water (EVLW), can now be clinically measured with minimally invasive Intensive Care Unit monitors (PiCCO2®, Pulsion Medical Systems) that also provides a physical estimate of pulmonary vascular permeability (PVPI). Similarly, biochemical correlates of vascular permeability (ICAM-1) and pneumocyte dysfunction (RAGE) can now be measured in plasma samples. Our study aims at quantifying physical and biochemical markers of PGD and assess their diagnosis and prognosis values.
26 studies on the registry are indexed under Primary Graft Dysfunction; 4 are open to participants now.
This study's planned enrollment of 45 is below the median of 60 across 13 observational studies indexed under Primary Graft Dysfunction.
Browse Primary Graft Dysfunction studies →University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.
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Lung transplant recipients cared for in Surgical Intensive Care Unit in Strasbourg University Hospital, France
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Diagnosis and prognosis values of extravascular lung water (EVLW) and pulmonary vascular permeability index (PVPI).
Time frame: H0 (At started lung transplantation), H6, H12, H24, H48, H72 after lung transplantation
Diagnosis and prognosis values of receptor for advanced glycation endproducts (RAGE) and intercellular adhesion
Time frame: H0 (At started lung transplantation), H6, H12, H24, H48, H72 after lung transplantation
The record gives a start of Jul 2010, a primary completion of Aug 2012 and a completion of Aug 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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University Hospital, Strasbourg, France →