Blinding

Q. Is there any risk of unblinding when administering the drug?

A. As the product is a black liquid the vein will go brown initially, but this is only temporary. To avoid unblinding if this occurs, a cover will be provided to place over the hand and arm. Also we suggest preparing the skin with an iodine swab so any discolouration will be harder to detect by the patient.

 

Q. Will patients know that they have had iron through changes in excretions?

A. This is a problem with oral iron due to the low percentage of absorption. There is no reason to believe this will be a problem with IV iron, and it was confirmed by experienced users that IV iron does not cause black stools, hence the patients will remain blinded.

 

Q. Will it be obvious from the many blood tests whether the patient has received iron or placebo?

A. Not necessarily. Certain values will be different in the run up to surgery anyway (e.g. Hb differences caused patients being nil by mouth prior to surgery). Full details of the blinding procedures will be included in the trial treatment SOP. Also the repeat blood samples taken at the ‘pre-operative’ trial visit are blinded to the centre.

 

Q. How do we avoid air bubbles when using the black giving sets?

A. You would run the solution through in advance and the normal protocols followed for IV administration. In other clinical trials where there has been product blinding this has not proved to be a problem.