Differences in coagulation between fresh frozen plasma and Solvent-detergent plasma in pediatric congenital heart surgery.

Differences in coagulation between fresh frozen plasma and Solvent-detergent plasma in pediatric congenital heart surgery. - FFP-Omni

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51227

Enrollment

120

Registered

2021-03-22

Start date

2021-07-12

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bloedstolling coagulation congenitale cardiac surgery

Interventions

None listed

Eligibility

Age

No minimum to 11 Years

Inclusion criteria

Inclusion criteria: · Informed consent · Cardiac surgery with the use of CPB · Group 1A and Group 2A children

Exclusion criteria

Exclusion criteria: · No informed consent · Cardiac surgery without the use of CPB · Preoperative known coagulation disorders · Known allergy for FFP or Omniplasma

Design outcomes

Primary

Measure	Time frame
Primary outcome involves the difference of coagulation variables between transfusion of FFP versus Omniplasma. Coagulation variables of interest are protein C activity, protein S activity, a2-antiplasmin, antithrombin, plasminogen, Hb, thrombocyte count, ROTEM, aPTT, PT and fibrinogen.	—

Secondary

Measure	Time frame
Secondary outcomes are clinical parameters as perioperative and postoperative blood loss, transfusion need, post-operative thrombosis until 30 days after surgery or until discharge from our hospital and costs between the two products.	—

Countries

Netherlands

Outcome results