ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Acute Lung Injury
Bleeding
Cardiac Defect
Congenital Heart Disease
Fibrinogenopenia; Acquired
Heart Defects, Congenital
Heart Diseases
Hemorrhage
Lung Injury
Surgery--Complications
Transfusion Reaction
Transfusion-Associated Circulatory Overload
Transfusion-Related Acute Lung Injury

Clinical Trial Details

NCT number	NCT04434001
Study type	Interventional
Source	IRCCS Policlinico S. Donato
Contact
Status	Terminated
Phase	Phase 2
Start date	February 27, 2020
Completion date	June 30, 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms