CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 159 enrolled
Drug / intervention
IV trivalent saccharose hydroxide ferrous +2 moredrug
Likely dose
IV trivalent saccharose hydroxide ferrous 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01078818
NCT01078818Phase 4Completed
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A Phase IV, Unicenter, Randomized, Double-Blind, Parallel-Group, Comparaty Study of Intravenous and Oral Iron vs Placebo in Patient Under Extracorporeal Circulation in Cardiovascular Surgery

Fundación Canaria Rafael Clavijo para la Investigación Biomédica·interventional·Posted Mar 2, 2010·Updated Mar 3, 2010

In Brief

A Phase 4 clinical trial evaluating IV trivalent saccharose hydroxide ferrous, Oral ferrous fumarate, and 1 other intervention for Anaemia. Completed, enrolled 159 participants across 1 site.

Detailed Summary

Anaemia is a common postoperative problem of cardiovascular surgery after cardiopulmonary bypass (CPB). Because of this the need for hemoderived blood transfusions is high. The purpose of this study was to compare the clinical efficacy of intravenous and oral iron in anaemia and the impact of the iron on the transfusion rate in postoperative cardiovascular surgery under extracorporeal circulation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnaemia
CountriesSpain
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2, 2010
Enrollment StartMay 1, 2007
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.3 years ago

Interventions

IV trivalent saccharose hydroxide ferrousdrug

Preoperative Period 5-10 days 200 mg Iron iv (Venofer® )in 200cc physiologic solution /24-48h x 3 dosis +1 oral placebo /24h Postoperative Period 1-3weeks 200 mg Iron iv (Venofer® )in 200cc physiologic solution/24-48h x 3 dosis + 1 oral placebo /24h One month Follow-up 1 month 1 oral placebo /24h

Oral ferrous fumaratedrug

200cc physiologic solution iv placebo /24-48h x 3 dosis + 1 oral iron tablet/24h (Ferogradumet®) Postoperative Period: 200cc physiologic solution iv placebo /24-48h x 3 dosis + 1 oral iron tablet/24h (Ferogradumet®) One month Follow-up: 1 oral iron tablet/24h Ferogradumet

Oral and intravenous Placebodrug

Preoperative Period:1oral placebo/24h Postoperative Period:200cc physiologic solution iv placebo /24-48h x 3 dosis + 1oral placebo/24h One month Follow-up:1 oral placebo/24h