Autopsy report · NCT04434001

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

“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.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 4 months after it had already started.
• Ran for about 1 year 4 months before it stopped.
• 40 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

IRCCS Policlinico S. Donato

Sponsor type

University, hospital or other

Conditions

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

Interventions

Fibrinogen Concentrate Human; Prothrombin Complex Concentrate; Fresh Frozen Plasma

Participants

40

Sites

1

Countries

Italy

Trials that died the same way

• Platelet Function With New Pediatric Oxygenator and Heparin and Non Heparin Coating in Pediatric Cardiac Surgery
  “for difficulty to enroll patients in the study” (58% match in meaning)
• Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)
  “difficulty of enrolling patients” (58% match in meaning)
• Non-pharmacological Treatments in Migraine.
  “Due to the unavailability of the subjects who gave the consent to participate to the study protocol” (58% match in meaning)
• Systemic Rapamycin (Sirolimus) to Prevent In-Stent Restenosis Following Pulmonary Artery Stent Placement
  “Unable to enroll appropriate patients” (57% match in meaning)
• Comparison of Ketamine and Etomidate During Rapid Sequence Intubation in Trauma Patients
  “Due to difficulties in obtaining consent because of emergency situation” (56% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.