The blood was then infused during the re-transfusion phase.
We hypothesize that the data from the first 21 days of illness represent his own serologic response, unaffected by the passive transfusion with convalescent-phase plasma on day 14; thus, these data were included in the analysis.
The clinical efficacy criterion was clinical response, defined as an increase in Hb concentration of ⩾2 g dl−1 during the treatment phase without transfusion requirement after the initial four treatment weeks.
First, patients admitted to one of six Canadian tertiary level intensive care units (ICUs) during 1993 were enrolled in a combined retrospective and prospective cohort study and, second, a bedside questionnaire was completed by physicians requesting blood transfusions during the prospective phase of the cohort study.
The percent change in recovery (upslope) was calculated as the difference between the StO2 upslopes of the reperfusion phase after and before transfusion divided by the StO2 upslope before transfusion.
The safety parameters evaluated in the study included incidence of adverse events, changes and abnormalities in laboratory safety parameters and incidence of red blood cell transfusions during the CERA treatment phase.
Of 148 transfusion-dependent MDS patients with del5q31, participating in a multicentre phase II trial of lenalidomide, 66% achieved transfusion independence (ITT analysis), achieving a median haemoglobin increase of 5.3 g dl−1.
If a patient had a transfusion within 28 days before the last treatment phase haemoglobin value, the last pretransfusion haemoglobin value was substituted to discount the effect of the transfusion on haemoglobin concentration.
In a multicentre, random ized, controlled Phase II trial, rFVIIa reduced red blood cell (RBC) transfusion requirements and the need for massive transfusion vs. placebo in patients with severe blunt trauma [ 2] and a confirmatory Phase III trial evaluating rFVIIa for the treatment of traumatic haemorrhage is ongoing.
Furthermore, two cohort studies showed that transfusion was safe and even beneficial during this early phase of septic shock [32, 33] and underlined that ScVO2 or lactate should be considered to trigger transfusion.
