No abstract

Reapplix ApS.

In previously independent individuals, cognitive impairment was common 3 months after stroke and related to increasing age, stroke severity, hypertension, atrial fibrillation, and cerebral atrophy on brain scanning. Cognition was related to dependency, disability, low mood, and quality of life. Hence, treatment directed toward reducing dependency might also reduce cognitive impairment.

Background: The LeucoPatch® device uses bedside centrifugation without additional reagents to generate a disc comprising autologous platelets, fibrin and leucocytes which is applied to the surface of the wound. The aim of the study was to test the effectiveness of LeucoPatch® on the healing of hard-to-heal foot ulcers in people with diabetes. Methods: 595 people with diabetes and a foot ulcer consented to participate. After a 4 week run-in-period those with a reduction in ulcer area of < 50% were randomised to either pre-specified good standard care alone or care supplemented by weekly application of LeucoPatch®. The primary outcome was percentage of ulcers healed within 20 weeks, defined as complete epithelialisation confirmed by an observer blind to randomisation group and maintained for four weeks. Results: 269 people were randomised; mean age 62 years, 82% male, 82% type 2 diabetes. In the intervention group 34.1% (n=45/132) of ulcers healed within 20 weeks vs. 21.6% (n=29/134) of the controls (OR 1.58, 95% CI 1.06-2.35; p= 0.02) by intention-to-treat analysis. Time to healing was shorter in the intervention group (p=0.0246) (Figure). No difference in adverse events was seen between groups. Interpretation: The use of LeucoPatch® is associated with significant enhancement of healing of hard-to heal foot ulcers in people with diabetes. Disclosure F. Game: Research Support; Self; Reapplix aps. W. Jeffcoate: Research Support; Self; Reapplix Aps, Urgo, France. L. Tarnow: Stock/Shareholder; Self; Novo Nordisk A/S. J.L. Jacobsen: Consultant; Self; Reapplix. D.J. Whitham: Other Relationship; Self; Reapplix. E.F. Harrison: Research Support; Self; Reapplix. S.J. Ellender: None. M. Londahl: Speaker's Bureau; Self; Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company. Advisory Panel; Self; Amgen Inc.. Speaker's Bureau; Self; AstraZeneca, Novo Nordisk A/S. Research Support; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; ReApplix AS.

Introduction. Romania ranks third worldwide for stroke mortality. Although high blood pressure (BP) is a major risk factor for stroke incidence and determinant of outcome, the management of BP in acute stroke remains undefined. The present study assesses patients recruited into the ‘Efficacy of Nitric Oxide in Stroke’ (ENOS) trial from Romania, one of 19 participating countries. Methods. ENOS is an international multicentre prospective randomised controlled trial that is assessing the safety and efficacy of: (i) lowering BP with transdermal glyceryl trinitrate, and (ii) whether pre-stroke antihypertensive therapy should be continued or stopped temporarily, in acute ischaemic stroke or primary intracerebral haemorrhage (PICH). Interventions are given for 7 days and the primary outcome, modified Rankin Scale (mRS), is measured at 90 days. Results. 135 patients were recruited from 3 Romanian sites between March 2009 and August 2011; 56% of these patients were also in the continue-stop arm of the trial. In comparison with the Rest of the World (RoW), Romanian patients were recruited earlier (29 vs. 22 hr), had a higher rate of previous high BP (63 vs. 76%), had less severe stroke at baseline (Scandinavian Stroke Scale, SSS 37 vs. 43/58), were less likely to have a PICH (17 vs. 10%), and had more cases of no visible stroke lesions on baseline CT (27 vs. 49%). Impairment (SSS) at day 7 did not differ. As compared to RoW, the length of stay in hospital was shorter in Romania (14 vs. 9 days); the adjusted death rate at follow-up at 90 days was doubled (odds ratio 1.97, 95% confidence intervals 1.07-3.63) although this was not reflected by a difference in the adjusted rate of death or dependency (mRS>2) at 90 days (OR 1.04, 95% CI 0.66-1.63). Conclusion. ENOS will continue recruiting patients until the summer of 2013. The presented data show that enrolment is feasible in Romania and the trial has been found to be easy to manage and recruit into.