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Fig. 3 Enrolment hours × qualification level interaction.
RAs will maintain a screening log of all potentially eligible patients during the study enrolment hours complete with reasons for exclusion.
A second log will also be maintained of those potentially eligible patients who present outside of the study enrolment hours to confirm that patient characteristics are similar.
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The mean time to enrolment was 6 hours after starting intravenous quinine (range 2 12 hours).
Septic patients were eligible for enrolment within 24 hours of their admission to the ICU, or within 36 hours of admission to the ward.
There was no association between stated times of first symptoms (average 4.0 days), times between emergency department arrival and enrolment (average 3.1 hours) and whether trajectories were increasing or decreasing at the first two time points.
Between T0 (enrolment) and T+6 hours, 44.4% received an intra-arterial, 37% a central venous and no patients a continuous central venous oxygen saturation catheter.
Further inclusion criteria are enrolment within 24 hours of admission and the patient must be willing and medically able to receive the study medication according to the protocol for the duration of the study.
Blood loss between enrolment and 6 hours later was significantly lower in the TA group than in the control group (median, 173 mL; first to third quartiles, 59 to 377) than in controls (221 mL; first to third quartiles 105 to 564) (P = 0.041).
All enrolled patients were intubated for at least 48 hours prior enrolment and they were aged above 18 years.
The primary outcome measures were specified prior to commencing the study: (1) measured blood loss ≥500 ml in 1 hour after enrolment; (2) mean measured blood loss in 1 hour after enrolment; (3) haemoglobin level day 1 after birth <6 g/dl or blood transfusion; (4) Side-effects (pyrexia 38.5°C or more, moderate or severe shivering 1 hour after enrolment).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com