Southport

Researchers are investigating whether adding duroplasty, a surgical procedure that expands the tough membrane around the spinal cord, improves outcomes after severe cervical spinal cord injury. This trial focuses on adults with acute, severe injuries in the neck area who require surgery within 72 hours. The study aims to determine if duroplasty combined with standard bony decompression surgery enhances muscle strength and functional recovery compared to bony decompression alone. Participants will be randomly assigned to receive either standard spinal surgery including laminectomy alone or the same surgery plus duroplasty. Some patients may also join an optional mechanistic sub-study where probes and microdialysis catheters monitor spinal cord pressure, blood flow, metabolism, and inflammation at the injury site. The study will recruit around 222 to 260 patients over four years, including sites in the UK and internationally. During the study, participants will be assessed at baseline, 3, 6, and 12 months after surgery using questionnaires and physical examinations to measure muscle strength, hand function, walking ability, bladder and bowel control, and quality of life. Some will have MRI scans at 2 weeks and 6 months, and safety outcomes such as complications, additional surgeries, and mortality will be tracked up to 12 months. Follow-up lasts one year to evaluate recovery and treatment impact.

Chronic obstructive pulmonary disease COPD is a common lung condition affecting many adults worldwide, with exacerbations leading to worsening health and hospital admissions. This trial focuses on patients recently discharged after a hospital stay for a COPD exacerbation, aiming to reduce the risk of readmission and improve outcomes during the critical 90-day high-risk period after discharge. The study is a phase 3, multicenter randomized controlled trial addressing an important healthcare challenge and potential cost savings for the NHS. The trial compares a supported rescue pack management plan to standard care. Participants in the supported rescue pack group receive a 5-day rescue pack of prednisolone and antibiotics, a written self-management plan based on the Asthma-Lung UK plan, and twice-weekly automated phone or text symptom assessments for 90 days. Those in the standard care group do not receive rescue packs on discharge but may access them through community care. The trial will monitor the use of rescue packs and support provided during the 90-day period. Participants will be involved in regular symptom monitoring through automated calls or texts and follow-up assessments. Researchers will measure time to first hospital readmission within 90 days as the primary outcome, along with secondary outcomes including readmission frequency, days alive and out of hospital, corticosteroid and antibiotic use, healthcare contacts, quality of life, and cost-effectiveness. Safety monitoring will include adverse events and antimicrobial resistance over an average of 4 years, with participant involvement lasting up to one year for some assessments.