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

October 28, 2021 updated by: Marco Ranucci, IRCCS Policlinico S. Donato

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • San Donato Milanese, MI, Italy, 20097
        • IRCCS Policlinico San Donato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • newborns and infants with weight lower than 10 kg undergoing cardiac surgery with extracorporeal circulation:
  • informed consent signed by both parents or legal guardian.

Exclusion Criteria:

  • emergency surgery;
  • known congenital coagulopathy or suspected based on anamnesis;
  • participation to other clinical trials;
  • known hypersensitivity to components and excipients of FFP , prothrombin complex concentrate or fibrinogen concentrate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ZEPLAST

In case of bleeding and:

  • CT INTEM > CT HEPTEM by 25% : give protamine 0.25 mg/kg;
  • MCF FIBTEM < 8 mm : give Fibrinogen Concentrate 30 mg/kg;
  • CT EXTEM > 100 s : give Prothrombin Complex Concentrate 20 mg/kg.
Drug: Fibrinogen Concentrate Human
Treatment of acquired postoperatively fibrinogen deficiency as assessed by ROTEM FIBTEM test.
Other Names:
  • Haemocomplettan
Drug: Prothrombin Complex Concentrate
Treatment of acquired postoperatively thrombin generation deficiency as assessed by ROTEM EXTEM test.
Other Names:
  • Confidex
ACTIVE_COMPARATOR: Control

In case of bleeding and:

  • CT INTEM > CT HEPTEM by 25% : give protamine 0.25 mg/kg;
  • fibrinogen and/or thrombin generation deficiency : give FFP 10-20 ml/kg.
Biological: Fresh Frozen Plasma
Treatment of acquired postoperative coagulopathy as assessed by ROTEM FIBTEM and INTEM tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transfusion of Fresh Frozen Plasma (FFP)
Time Frame: First 48 hours after surgery
Number of patients transfused with FFP
First 48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative bleeding
Time Frame: First 12, 24 and 48 hours after surgery
Amount of blood collected by chest drainages
First 12, 24 and 48 hours after surgery
Severe bleeding
Time Frame: First 12 hours after surgery
Number of patients who experienced severe bleeding (higher than 30 ml/kg in the first 12 hours after surgery)
First 12 hours after surgery
Surgical re-exploration for bleeding
Time Frame: First 12, 24 and 48 hours after surgery
Number of patients requiring surgical re-exploration due to bleeding (bleeding with no coagulopathies detected or refractory to pharmacological treatment)
First 12, 24 and 48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Donato

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 27, 2020

Primary Completion (ACTUAL)

May 31, 2021

Study Completion (ACTUAL)

June 30, 2021

Study Registration Dates

First Submitted

June 12, 2020

First Submitted That Met QC Criteria

June 12, 2020

First Posted (ACTUAL)

June 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 3, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZEPLAST-PED

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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