METHODS: This is a prospective cohort study on offshore platforms in the United States, Malaysia, and the United Kingdom. Emergency evacuation rates were compared between locations with telemedicine (United States) and 2 control groups without telemedicine (Malaysia, United Kingdom).
RESULTS: Three hundred eighty-four cases in the telemedicine group and 261 cases in the control groups were included. The odds (adjusted and unadjusted) of medical evacuation were significantly higher for assets without telemedicine, contractors, and age older than 60 years. Analysis indicated a shift from emergency evacuation to routine transport for the telemedicine group.
CONCLUSIONS: Telemedicine reduces emergency medical evacuations from offshore installations. This reduction is likely due to an increased capacity for transforming emergency care into routine care at the offshore location.
AIM: To investigate the safety and efficacy of rVIII-SingleChain in previously untreated patients (PUPs).
METHODS: In an open-label, phase 3, extension study, PUPs with severe haemophilia A (FVIII <1%) received rVIII-SingleChain prophylactically or on-demand. The primary endpoints were incidence of high-titre (HT) inhibitor formation to FVIII, treatment success for major bleeding episodes and annualised spontaneous bleeding rate (AsBR).
RESULTS: Twenty-four PUPs (median age 1 year [range 0-5]) were treated with rVIII-SingleChain; median time on study was 35.0 months (range 2.4-54.0). Overall, six PUPs developed a HT inhibitor (>5 BU/mL) and six developed a low-titre (LT) inhibitor (≤5 BU/mL). The median number of exposure days at inhibitor development was 10 (interquartile range [IQR] 5.0-14.0). Of 11 inhibitor-positive PUPs (five HT, six LT) who continued rVIII-SingleChain therapy, nine (81.8%; three HT, six LT) achieved inhibitor eradication (<0.6 BU/mL). Median time to eradication was 14.3 weeks (IQR 9.8-53.8). Seventeen treatment-emergent adverse events in 12 PUPs (50.0%) were related to rVIII-SingleChain, mainly inhibitor development (14/17 events). Treatment was successful (haemostatic efficacy rated excellent or good) for 290/315 bleeding events (92.1%). During prophylactic therapy, inhibitor-negative PUPs had a median (IQR) AsBR of 0.52 (0.00-4.99) and annualised bleeding rate of 1.98 (0.77-11.23).
CONCLUSION: RVIII-SingleChain demonstrated a satisfactory benefit:risk profile in PUPs, with a high treatment success rate and a low AsBR during prophylaxis, and was effective at eradicating inhibitors.