TMP0916-03_IDA II, Iron Defciency Anemia in PostOP patients
Research type
Research Study
Full title
Safety and efficacy of postoperative i.v. iron substitution with Polyglucoferron compared to Ferric Carboxymaltose and oral iron in patients with diagnosed iron deficiency who develop anaemia peri- or postoperatively (IDA II).
IRAS ID
255202
Contact name
Ravishankar Raobaikady
Contact email
Sponsor organisation
Fraunhofer Gesellschaft for its Institute - Fraunhofer IME
Eudract number
2017-003439-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 17 days
Research summary
Iron deficiency and consequent postoperative (after operation) anaemia (disorder of blood formation), when left untreated, dramatically increases the risk of complications and mortality from surgical procedures. Amongst others, postoperative anaemia is dependent on preoperative (before operation) iron status and is associated with an increased risk of morbidity and mortality. Therefore, early diagnosis and treatment of iron deficiency anaemia is of great importance to optimize the postoperative outcome. Observational studies have shown that the presence of iron deficiency anaemia (IDA) is associated with an increased risk of morbidity and mortality during and after surgery. Therefore diagnosing and treating IDA early, before (pre-operative) or after surgery is of great importance. Therefore, we would like to investigate if an iron substitution through the vein may have a stronger effect on IDA with better tolerability and shorten overall treatment duration.
In this trial 407 patients, aged 18 years or older with iron deficiency (ID) prior to a major surgery, who develop an iron deficiency anaemia (IDA), a disorder of blood formation, during or shortly after surgery, triggered due to blood loss during surgery. Patients will receive either Polyglucoferron (infusion into the vein), Ferric Carboxymaltose (infusion into the vein) or oral iron tablets. The participation per patient will last approximately 10 weeks.
The study is sponsored by the Fraunhofer IME represented by Dr. Frank Behrens, head of the Fraunhofer branch for Translational Medicine and Pharmacology in Frankfurt/Main - Germany. The Fraunhofer branch for TMP works closely with the Department of Anaesthesiology, Intensive Medicine and Pain Therapy at the University Hospital Frankfurt (Germany). The study is financially supported by Iron4U, located in Denmark. The Clinical Care Unit (CCU) and Anaesthetics department of The Royal Marsden NHS Foundation Trust located in the UK will also co-investigate this study.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0215
Date of REC Opinion
20 May 2020
REC opinion
Further Information Favourable Opinion