Differences in coagulation between fresh frozen plasma and Solvent-detergent plasma in pediatric congenital heart surgery
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Primary outcome involves the difference of coagulation variables measured just after surgery between FFP or Omniplasma use. The coagulation variables of interest are protein C activity, protein S activity, α2-antiplasmin, antithrombin, plasminogen, Hb, thrombocyte count, ROTEM, aPTT, PT and fibrinogen.
Study Overview
Brief Summary
To investigate the differences in coagulation variables just after surgery between FFP and S/D plasma (Omniplasma) use. The main coagulation variables of interest are protein S activity and α2-ntiplasmin. Other important coagulation variables are aPTT, PT, ROTEM, fibrinolysis (measured with ROTEM) fibrinogen, Hb, thrombocyte count, protein C activity, antithrombin and plasminogen.
Eligibility Criteria
- Ages
- 0 years to 17 years (0-17 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Informed consent
- •Cardiac surgery with the use of CPB
- •Group 1A and Group 2A children < 1 year old
- •Group 1B and Group 2B Glenn / Fontan surgery
Exclusion Criteria
- •No informed consent
- •Cardiac surgery without the use of CPB
- •Preoperative known coagulation disorders
- •Known allergy for FFP or Omniplasma
Outcomes
Primary Outcomes
Primary outcome involves the difference of coagulation variables measured just after surgery between FFP or Omniplasma use. The coagulation variables of interest are protein C activity, protein S activity, α2-antiplasmin, antithrombin, plasminogen, Hb, thrombocyte count, ROTEM, aPTT, PT and fibrinogen.
Primary outcome involves the difference of coagulation variables measured just after surgery between FFP or Omniplasma use. The coagulation variables of interest are protein C activity, protein S activity, α2-antiplasmin, antithrombin, plasminogen, Hb, thrombocyte count, ROTEM, aPTT, PT and fibrinogen.
Secondary Outcomes
No secondary outcomes reported
Investigators
Research office Cardiothoracic Surgery
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)