Congenital cardiac diseases needing surgical correction requiring intervention with extracorporeal circulation
Conditions
Interventions
Trade Name: Albumin 5%
Product Name: Albumin
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
IRCCS Policlinico San Donato
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Weight lower than 10 kg Cardiac surgery requiring cardiopulmonary bypass Need for hematic priming Elective surgery Informed consent signed by the parents or people delegated with parental authority Are the trial subjects under 18? yes Number of subjects for this age range: 80 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Congenital diseases of hemostasis and coagulation Emergency surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the effects of extracorporeal circulation circuit priming containing Albumin 5% versus fresh frozen plasma of hemostasis and coagulation;Secondary Objective: Not applicable;Primary end point(s): Postoperative bleeding reduction (ml/kg);Timepoint(s) of evaluation of this end point: First 12 postoperative hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Blood products (red blood cells, fresh frozen plasma, platelets) consumption ;Timepoint(s) of evaluation of this end point: From the start of cardiopulonary bypass till the first 48 hours after surgery | — |
Countries
Italy
Contacts
Public ContactStudy Coordinator
IRCCS Policlinico San Donato
Outcome results
None listed