Clinical study comparing the performance of two substances, albumin and plasma, during cardiac operations of pediatric patients.
Phase 1
- Conditions
- Congenital cardiac diseases needing surgical correction requiring intervention with extracorporeal circulationTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2014-000177-39-IT
- Lead Sponsor
- IRCCS Policlinico San Donato
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
Congenital diseases of hemostasis and coagulation
Emergency surgery
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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