The primary objective is to identify biomarkers measured in donor and recipient blood before lung transplantation which can predict lung graft function after lung transplantation. When the risk of PGD can be predicted, more adequate therapy can be…
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is primary graft dysfunction in the first 72 hours as
defined by a classification system from the international society for heart and
lung transplantation.
Secondary outcome
1. Assessment of biomarkers, measured during and post operation (in the
recipient), that correlates with the graft function after lung transplantation.
2. Assessment of biomarkers, measured during and post operation (in the
recipient), that quantifies primary graft dysfunction.
Background summary
The main reason for early morbidity and mortality after lung transplantation is
primary graft dysfunction (PGD). There are several factors that may influence
the occurrence of PGD (such as; brain death, mechanical ventilation,
hypotension, trauma or pneumonia) but there is no variable as yet, measured in
a donor blood sample, that can predict the occurrence of PGD. Although donor
variables strongly influence the occurrence of PGD, also recipient variables
contribute to the occurrence of PGD.
Study objective
The primary objective is to identify biomarkers measured in donor and recipient
blood before lung transplantation which can predict lung graft function after
lung transplantation. When the risk of PGD can be predicted, more adequate
therapy can be applied, preventing severe morbidity and mortality.
Study design
Prospective cohort study
Study burden and risks
The burden of participation is that during the first 72 hours after
transplantation a total of 75ml of blood will be taken out off the venous or
arterial line. These lines are part of standard care. No further physical or
mental burden is present. No increased risk is inflicted. In case of removal of
venous and arterial lines, blood will be sampled by vena punction during
standard blood sampling for clinical use. The study relates to recipients with
a lungtransplant, who due to objective research factors only influence PGD in
lung transplantation.
A. Deusinglaan 1
9713 AV
NL
A. Deusinglaan 1
9713 AV
NL
Listed location countries
Age
Inclusion criteria
Age ><= 18 years
First lung transplantation
Informed consent
Exclusion criteria
Hyperacute rejection
Venous anastomotic obstruction
Cardiogenic pulmonary edema
Pneumonia (both viral and bacterial pneumonias will be considered)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30984.042.10 |