Is the application of allogeneic fibrin sealant in CABG surgery feasible and effective in stopping bleedings/restore hemostasis after restoring the blood flow?
ID
Source
Brief title
Condition
- Other condition
- Coronary artery disorders
Synonym
Health condition
bloedingen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Numbers of bleedingstops/complete hemostasis, at least 5 minutes after
restoration of the blood flow.
Secondary outcome
Number of anastomoses
Number of bleedings stopped
Nummer of bloedtransfusies
Amounts of ml fibrin sealant applied
Background summary
Sanquin blood supply has been engaged by ZonMw to submit a research proposal of
a multi-centre randomised controlled trial (RCT) to study the costeffectiveness
of CryoSeal (fa. Thermogenesis) fibrin sealant in bypass surgery in the Dutch
Health Care. Before applying, Sanquin wants to demonstrate in CABG surgery the
feasibility and effectiveness of fibrin sealant composed of allogenous plasma
from blood donors.
Study objective
Is the application of allogeneic fibrin sealant in CABG surgery feasible and
effective in stopping bleedings/restore hemostasis after restoring the blood
flow?
Study design
Observationeel clinil trial of patients who are undergo CABG (coronairy
bypass)surgery. Coagulation times are registrered starting at the moment the
fibrin sealant is applied, in addition to registration of the amounts of fibrin
sealant used, number of bypasses, duration on-pump, number of bleedings stopped
and given transfusions.
Study burden and risks
nihil to very low additional risks
Plesmanlaan 1a
2333 BZ Leiden
Nederland
Plesmanlaan 1a
2333 BZ Leiden
Nederland
Listed location countries
Age
Inclusion criteria
CABG patients with a minimum age of 18 years
Revisions of CABG
Exclusion criteria
Patients with congenital or acquired coagulation deseases
Patients with thrombopenia, < 100 x 10*9 PLT/L
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 | NL15994.058.07 |