Eligibility
Q. Laparoscopic surgery patients have been excluded, does this exclusion count for any conversion operations or robotic operations? And why are you excluding laparoscopic procedures?
A. Yes, this exclusion includes conversion and robotic operations. We are currently excluding laparoscopic patients because overall laparoscopic surgery has a lower blood transfusion rate, and if we included such patients then we would need to recruit a higher number. The Trial Steering Committee has agreed to review this should there be problems with recruitment, but at present we are not including laparoscopic patients.
Q. Why have you chosen to exclude patients who are having laparoscopic rather than open surgery?
A. We have decided to exclude patients having a laparoscopic procedure as the primary endpoint for PREVENTT is blood transfusion. Data suggest that laparoscopic resection is associated with a lower blood transfusion rate, therefore more patients would be required for the trial. If we have any problems recruiting, this may be reviewed by the Trial Steering Committee at a later date
Q. Many patients that are geriatric may come in with a previously undiagnosed condition, for example B12 or folate deficiency. Will these be excluded from the trial?
A. If there is a known cause for anaemia that is not iron deficiency or anaemia of chronic disease these patients will be excluded.
Q. The exclusion criteria states that anyone undergoing immunosuppressive therapy or renal dialysis (current or planned within the next 12 months) should be excluded. Does this exclude patients whose pathology requires them to have post op chemotherapy?
A. No. Patients undergoing routine perioperative chemotherapy or radiotherapy are fine to include. It is only the patients undergoing long-term immunosuppression e.g. for transplantation that should be excluded.
Q. How is severe asthma or severe allergy defined?
A. Hospital inpatient admission with a diagnosis of severe asthma or severe allergy for treatment in the past year.
Q. Can patients who have a treated vitamin B12 deficiency or folate deficiency (eg. with vitamin B12 injections) be randomised into the trial?
A. Yes, these patients can be randomised into the trial.
Q. Can patients with iron deficient anaemia be randomised into the trial?
A. Yes, these patients can be randomised into the trial.
Q. Can patients with microcytic anaemia be randomised into the trial?
A. Yes, these patients can be randomised into the trial as microcytic anaemia relates to the size of the red blood cells. In general patients who are iron deficient have a microcytic anaemia (although there can be other causes).
Q. Can patients with thalassaemia be randomised into the trial?
A. Patients with confirmed thalassaemia or thalassaemia trait should not be recruited. If the patient has a proven or suspected haemoglobinopathy, please discuss with your local haematologist to confirm that blind administration is appropriate and safe.
