WHO ICTRP trial

Iron Deficiency in cardiac surgery

EUCTR2017-001823-26-IT · EU Clinical Trials Register · Authorised

Key facts

Trial ID EUCTR2017-001823-26-IT
Public title Iron Deficiency in cardiac surgery
Scientific title Efficacy and Safety of Intravenous Ferric Carboxymaltose in Patients Undergoing Cardiac Surgery A Randomized Controlled Study - IDECAS RCT 3.0
Primary sponsor UNIVERSITÀ CAMPUS BIO-MEDICO DI ROMA
Registry EU Clinical Trials Register
Recruitment status Authorised
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries Italy
Conditions Iron deficiency in cardiac surgery MedDRA version: 20.0 Level: LLT Classification code 10067709 Term: Hypoferrism System Organ Class: 100000004861 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Interventions Trade Name: FERINJECT - 50 MG/ML SOLUZIONE INIETTABILE O PER INFUSIONE 1 FLACONCINO IN VETRO DA 20 ML Product Name: Ferinject Product Code: 40251074 Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN…
Registration date Aug 6, 2021
Target size 50
Secondary IDs IDECASRCT;19032016
Registry page clinicaltrialsregister.eu

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