NCT04434001

ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery

ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery Randomized Controlled Pilot Phase II Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: IRCCS Policlinico S. Donato · Academic / Other
• Sex: All
• Age: 1 Day – 2 Years
• Healthy volunteers: Not accepted

Summary

In pediatric patients (newborns and infants weighing less than 10 kg) undergoing cardiac surgery with extracorporeal circulation postoperative bleeding represents a known complication with a significant impact on outcome. Fresh frozen plasma (FFP) for bleeding management is associated, particularly in this kind of patients, to volume overload and a significative increase of Transfusion Related Acute Lung Injury (TRALI), further worsening the postoperative outcome. In the adult patient FFP employment could be almost completely canceled by administration of concentrated hemostatic components - the fibrinogen concentrate and prothrombin complex concentrate (PCC). We designed this phase II pilot study to establish whether an analogous strategy, modified accordingly to pediatric physiology, could be safely and successfully applied in newborns and infants.

Detailed description

The study population will be randomized to two groups: ZEPLAST and control, respectively. The two groups will receive the same priming solution (containing Red Blood Cells and albumin 5%) and heparin/protamine management. In both groups coagulation will be assessed with rotational thromboelastometry (ROTEM - EXTEM, INTEM, HEPTEM and FIBTEM tests) after heparin antagonization. In case of bleeding, coagulopathies will be treated differently: * in the ZEPLAST group, fibrinogen deficiency (FIBTEM Maximum Clot Firmness MCF \< 8 mm) will be treated with 30 mg/kg of concentrated fibrinogen; low thrombin generation (EXTEM Clotting Time CT \> 100 s) will be treated with 20 mg/kg of prothrombin complex concentrate; * in the control group, coagulopathies will be treated with 10-20 ml/kg of FFP. In case of refractory bleeding, PCC and fibrinogen can be administered as a rescue treatment. Further ROTEM tests will be performed at 24 and 48 hours post surgery. Outcome parameters will be collected at the same timepoints.

Conditions

• Bleeding
• Cardiac Defect
• Surgery--Complications
• Fibrinogenopenia; Acquired
• Transfusion-Related Acute Lung Injury
• Transfusion-Associated Circulatory Overload
• Congenital Heart Disease

Interventions

Type	Name	Description
DRUG	Fibrinogen Concentrate Human	Treatment of acquired postoperatively fibrinogen deficiency as assessed by ROTEM FIBTEM test.
DRUG	Prothrombin Complex Concentrate	Treatment of acquired postoperatively thrombin generation deficiency as assessed by ROTEM EXTEM test.
BIOLOGICAL	Fresh Frozen Plasma	Treatment of acquired postoperative coagulopathy as assessed by ROTEM FIBTEM and INTEM tests.

Timeline

• Start date: 2020-02-27
• Primary completion: 2021-05-31
• Completion: 2021-06-30
• First posted: 2020-06-16
• Last updated: 2021-11-03

Locations

1 site across 1 country: Italy