Find out whether fibrin clots applied to the pericardial sac might be suitable drug-delivery systems.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
er wordt slechts gekeken naar normale fysiologie, niet naar aandoeningen/ziekten.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Fibrin clot weight after 60 minutes of intrapericardial incubation
(specifically: clot weight reduction compared to starting clot weight).
Secondary outcome
-
Background summary
Within medicine, e.g. ENT, plastic surgery, autologous fibrin clots have been
used as slow-release drug delivery systems. The pericardial sac has proven to
be a site for local therapy for heart and coronaries. Therapeutics become
available when fibrinolysis degrades the fibrin clots. In order to serve as a
slow-release drug delivery system, fibrin clots need to be able to survive in
the pericardial sac for a couple of days. Fibrin degradation characteristics
when applied to the pericardial sac are currently largely unknown.
Study objective
Find out whether fibrin clots applied to the pericardial sac might be suitable
drug-delivery systems.
Study design
Observational study without invasive measurements.
Study burden and risks
Naar onze mening brengt het bovenbeschreven observationeel onderzoek geen
risico*s voor de patiënt met zich mee. Tijdens reguliere hartchirurgie loopt
vaak een beperkte hoeveelheid vers bloed (enkele tientallen ml.*s) uit het
operatiegebied in het hartzakje. Dit is inherent aan de procedure die
plaatsvindt en brengt voor de patiënt geen risico*s met zich mee voor wat
betreft beperking van hartfunctie.
De operatieduur zal door deze observationele studie niet worden verlengd.
As indicated above, to our opinion, no additional risks are associated with
this observational study. Furthermore, the observation will not result in time
loss during the cardiac surgery.
P. Debyelaan 25
6229 HX Maastricht
Nederland
P. Debyelaan 25
6229 HX Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
All patients undergoing coronary artery bypass grafting and/or valve surgery via sternotomy.
Exclusion criteria
previous cardiac surgery.
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 | NL17443.068.07 |