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

> **NCT04434001** · PHASE2 · TERMINATED · sponsor: **IRCCS Policlinico S. Donato** · enrollment: 40 (actual)

## Conditions studied

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

## Interventions

- **DRUG:** Fibrinogen Concentrate Human
- **DRUG:** Prothrombin Complex Concentrate
- **BIOLOGICAL:** Fresh Frozen Plasma

## Key facts

- **NCT ID:** NCT04434001
- **Lead sponsor:** IRCCS Policlinico S. Donato
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2020-02-27
- **Primary completion:** 2021-05-31
- **Final completion:** 2021-06-30
- **Target enrollment:** 40 (ACTUAL)
- **Why stopped:** The study encountered unexpected difficulties in enrolling patients due to requirements for the Informed Consent. 60% of our patients comes from abroad with only one accompanying parent. The rules of our EC require both parents to sign the consent.
- **Last updated:** 2021-11-03


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04434001

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04434001, "ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT04434001. Licensed CC0.

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