Research to study the difference in coagulation between two different kinds of blood plasma products in heart surgery in children.

Differences in coagulation between fresh frozen plasma and Solventdetergent plasma in pediatric congenital heart surgery - FFP-OMNI

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000444-22-NL

Enrollment

120

Registered

2021-03-22

Start date

2021-04-07

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

coagulation in pediatric cardiac surgery

Interventions

Trade Name: Omniplasma Product Name: Omniplasma Product Code: RVG 25407 Pharmaceutical Form: Solution for infusion Product Name: fresh frozen plasma Pharmaceutical Form: Infusion INN or Proposed INN:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: · Informed consent · Cardiac surgery with the use of CPB · Group 1A and Group 2A children =65 years) no F.1.3.1 Number of subjects for this age range

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
Main Objective: Primary Objective: 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 a2-antiplasmin. Other important coagulation variables are aPTT, PT, ROTEM, fibrinolysis (measured with ROTEM) fibrinogen, Hb, thrombocyte count, protein C activity, antithrombin and plasminogen. ;Secondary Objective: Secondary outcomes are the coagulation variables 24 hours after surgery compared to the pre-operative values and clinical parameters such as perioperative and postoperative blood loss, transfusion need and thrombotic events until 30 days after surgery or until discharge from our hospital. In addition, we also investigate if there are differences in costs between the two products. ;Primary end point(s): 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, a2-antiplasmin, antithrombin, plasminogen, Hb, thrombocyte count, ROTEM, aPTT, PT and fibrinogen. ;Timepoint(s) of evaluation of this end point: Together with routine sampling from an indwelling catheter placed under anaesthesia, 3 times 2,7ml blood in 24h hours (shortly before surgery, shortly after and around 24 hours after cardiac surgery) will be taken.	—

Measure

Time frame

Main Objective: Primary Objective: 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 a2-antiplasmin. Other important coagulation variables are aPTT, PT, ROTEM, fibrinolysis (measured with ROTEM) fibrinogen, Hb, thrombocyte count, protein C activity, antithrombin and plasminogen. ;Secondary Objective: Secondary outcomes are the coagulation variables 24 hours after surgery compared to the pre-operative values and clinical parameters such as perioperative and postoperative blood loss, transfusion need and thrombotic events until 30 days after surgery or until discharge from our hospital. In addition, we also investigate if there are differences in costs between the two products. ;Primary end point(s): 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, a2-antiplasmin, antithrombin, plasminogen, Hb, thrombocyte count, ROTEM, aPTT, PT and fibrinogen. ;Timepoint(s) of evaluation of this end point: Together with routine sampling from an indwelling catheter placed under anaesthesia, 3 times 2,7ml blood in 24h hours (shortly before surgery, shortly after and around 24 hours after cardiac surgery) will be taken.

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary outcomes are the coagulation variables 24 hours after surgery compared to the pre-operative values and 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. ;Timepoint(s) of evaluation of this end point: 30 days	—

Measure

Time frame

Secondary end point(s): Secondary outcomes are the coagulation variables 24 hours after surgery compared to the pre-operative values and 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. ;Timepoint(s) of evaluation of this end point: 30 days

—

Countries

Netherlands

Contacts

Public ContactI de Liefde

Erasmus MC

i.deliefde@erasmusmc.nl+31107040704

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026