PREVENNT

PREVENNT was a double blind RCT that randomised anaemic patients (males 90>Hb<130 and females 90>Hb<120) undergoing major surgery to placebo or 1000mg Ferinject pre-operatively. Laparoscopic surgeries and patients weighing >< 50kg were excluded.Surgical specialties included upper GI (34%), Gynaecology (30%), Colorectal (15%), and Urology (12%). 86% patients had preop haemoglobin > 100g/L and 25% had preop haemoglobin >120g/L. 57% patients had Ferritin <100 and 76% TSAT >< 20, which would meet criteria for relative iron deficiency. Median duration of therapy was 14 days.

In the Ferinject group pre-operative Haemoglobin rose by an average of 4.7 g/L from 111.2 g/L to 115.9 g/L. 21% of the Ferinject group were no longer anaemia compared with 10% of controls.

There was no difference in primary endpoints of transfusion, mortality or complications. Haemoglobin in the first 2 post-operative weeks did not differ between groups.

 

The Ferinject group had higher haemoglobin at week 8 and 6 months. Readmission rates at 8 weeks were also lower, but no difference in 6 month mortality was noted.

Points to note are:

1. The treatment time frame may have been too short (with 21% anaemia correction) to demonstrate an effect.
2. Iron deficient patients were not specifically studied - albeit subgroup analysis of this cohort showed no additional benefit
3. 1000mg Ferinject may have been inadequate dosing for some patients

BUT in terms of pragmatic “real life” practice PREVENNT tells us that despite anaemia and Fe deficiency being common, IV Ferinject in the immediate pre-operative period for undifferentiated anaemic patients does not influence outcome.