Here is the design of a clinical trial:

Official Title: A Randomized Clinical Trial Assessing the Effect of "Optimal" Cerebral Perfusion Pressure Monitoring in the Management of Severe Traumatic Brain Injury

Included conditions:
- Brain Injuries, Traumatic
- Cerebrovascular Circulation
- Homeostasis

Study Armgroups:
- {'label': 'CPPopt intervention group', 'type': 'EXPERIMENTAL', 'description': 'Patients are managed according to Brain Trauma Foundation guidelines, except for CPP where the CPPopt is targeted.', 'interventionNames': ['Other: For both groups, CPP targets will be achieved first by ICP control if this is raised and then by ABP support by titration (up or down) of vasopressors and fluids according to local protocols.']}
- {'label': 'CPP control group', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients are managed according to Brain Trauma Foundation guidelines with CPP between 60 and 70 mmHg.\n\nCPPopt information is recorded but hidden for the treating clinicians.', 'interventionNames': ['Other: For both groups, CPP targets will be achieved first by ICP control if this is raised and then by ABP support by titration (up or down) of vasopressors and fluids according to local protocols.']}

Interventions:
- {'type': 'OTHER', 'name': 'For both groups, CPP targets will be achieved first by ICP control if this is raised and then by ABP support by titration (up or down) of vasopressors and fluids according to local protocols.', 'description': 'For both groups, CPP targets will be achieved first by ICP control if this is raised and then by ABP support by titration (up or down) of vasopressors and fluids according to local protocols.', 'armGroupLabels': ['CPP control group', 'CPPopt intervention group']}

Primary Outcomes:
- {'measure': 'Percentage of monitoring time with measured CPP within 5 mmHg of calculated CPPopt', 'description': 'Main feasible endpoint: In pilot studies, we showed that, on average, patients spent a mean (+SD) of 30% ( 8%) of their monitored time with measured CPP within 5 mmHg of CPPopt. The study will be powered to target an increase in this metric to 50% of monitored time.', 'timeFrame': 'First 5 days during intensive care unit admission'}

Please estimate the sample size based on the assumption: 
A significance level of 5% and power of 80% were assumed. The analyses will be conducted according to the intention-to-treat principle. The sample size was increased to account for dropout, technical problems, or the need for non-parametric analysis.
Sample size
        The sample size justification is based on the primary endpoint for the feasibility objective. The analyses will be conducted according to the intention-to-treat principle, therefore all the enrolled and randomised patients will be included in the analysis, regardless of their compliance with the protocol. Sample sizes were determined using the R statistical language19 and the PWR package.20 A significance of 5% and power of 80% were assumed.
        As described in the outcome measures paragraph, the primary endpoint for the main objective, feasibility, is the percentage of monitored time with measured CPP within a range of 5âmm Hg above or below CPPopt. Retrospective analysis in unpublished data showed that on average patients spent a mean (+SD) of 30% (+8%) of their monitored time with measured CPP within 5âmm Hg of CPPopt. In the absence of prospective data, we powered COGiTATE study to target a relative increase in CPPopt target adherence by 20% (a pragmatic choice but justifiable on typical differences seen between good/poor outcome in the retrospective data), that is, from 30% to 36% of monitored time within the CPPopt target margin, while keeping the SD at 8%. This produced a desired sample size of 56, which was increased to 60 patients, to allow for dropout, technical problems or need for a non-parametric analysis.
        The primary endpoint for the safety secondary objective is to assess whether there is an increase of the daily TIL score of >3 in the CPPopt treatment arm. We regard an increase of daily TIL of 3 as a significant effect as it represents a difference comparable to one treatment tier and in comparison with typical TIL variability from pilot data. Conversely, a TIL score increase of 2 can be expected in the intervention group because two points are counted for CPP-related therapy (vasopressor therapy/fluids), so this could be not interpreted as a significant worsening of TBI therapy. We estimate, for 80% power and 5% significance an averaged change in daily TIL score of 3 would require an n=25 in each arm (although this is a secondary endpoint and this estimation does not correct for multiple comparisons).