Statistical analysis plan of the head position in acute ischemic stroke trial pilot (HEADPOST pilot)

2016 ◽  
Vol 12 (2) ◽  
pp. 211-215
Author(s):  
Verónica V Olavarría ◽  
Hisatomi Arima ◽  
Craig S Anderson ◽  
Alejandro Brunser ◽  
Paula Muñoz-Venturelli ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Statistical Analysis ◽  
Pilot Study ◽  
Acute Ischemic Stroke ◽  
Transcranial Doppler ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Head Position ◽  
Process Of Care ◽  
Anterior Circulation

Background The HEADPOST Pilot is a proof-of-concept, open, prospective, multicenter, international, cluster randomized, phase IIb controlled trial, with masked outcome assessment. The trial will test if lying flat head position initiated in patients within 12 h of onset of acute ischemic stroke involving the anterior circulation increases cerebral blood flow in the middle cerebral arteries, as measured by transcranial Doppler. The study will also assess the safety and feasibility of patients lying flat for ≥24 h. The trial was conducted in centers in three countries, with ability to perform early transcranial Doppler. A feature of this trial was that patients were randomized to a certain position according to the month of admission to hospital. Objective To outline in detail the predetermined statistical analysis plan for HEADPOST Pilot study. Methods All data collected by participating researchers will be reviewed and formally assessed. Information pertaining to the baseline characteristics of patients, their process of care, and the delivery of treatments will be classified, and for each item, appropriate descriptive statistical analyses are planned with comparisons made between randomized groups. For the outcomes, statistical comparisons to be made between groups are planned and described. Results This statistical analysis plan was developed for the analysis of the results of the HEADPOST Pilot study to be transparent, available, verifiable, and predetermined before data lock. Conclusions We have developed a statistical analysis plan for the HEADPOST Pilot study which is to be followed to avoid analysis bias arising from prior knowledge of the study findings. Trial registration The study is registered under HEADPOST-Pilot, ClinicalTrials.gov Identifier NCT01706094.

scholarly journals Statistical analysis plan for the Head Position in Stroke Trial (HeadPoST): An international cluster cross-over randomized trial

2017 ◽  
Vol 12 (6) ◽  
pp. 667-670 ◽  
Author(s):  
Laurent Billot ◽  
Mark Woodward ◽  
Hisatomi Arima ◽  
Maree L Hackett ◽  
Paula Muñoz Venturelli ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Statistical Analysis ◽  
Acute Stroke ◽  
Acute Ischemic Stroke ◽  
Statistical Analysis Plan ◽  
Head Position ◽  
Process Of Care ◽  
Head Positioning ◽  
Cluster Randomized ◽  
Stroke Trial

Background There is evidence to indicate that the lying flat head position increases cerebral blood flow and oxygenation in patients with acute ischemic stroke, but how these physiological effects translate into clinical outcomes is uncertain. The Head Position in Stroke Trial aims to determine the comparative effectiveness of lying flat (0°) compared to sitting up (≥30°) head positioning, initiated within 24 h of hospital admission for patients with acute stroke. Design An international, pragmatic, cluster-randomized, crossover, open, blinded outcome assessed clinical trial. Each hospital with an established acute stroke unit (cluster) site was required to recruit up to 140 consecutive cases of acute stroke (one phase of head positioning before immediately crossing over to the other phase of head positioning), including both acute ischemic stroke and intracerebral hemorrhage, in each randomized head position as a ‘business as usual’ policy. Objective To outline in detail the predetermined statistical analysis plan for the study. Methods All accumulated data will be reviewed and formally assessed. Information regarding baseline characteristics of patients, their process of care and management will be outlined, and for each item, statistically relevant descriptive elements will be described. For the trial outcomes, the most appropriate statistical comparisons are described. Results A statistical analysis plan was developed that is transparent, verifiable, and predetermined before completion of data collection. Conclusions We developed a predetermined statistical analysis plan for Head Position in Stroke Trial to avoid analysis bias arising from prior knowledge of the findings, in order to reliably quantify the benefits and harms of lying flat versus sitting up early after the onset of acute stroke. Trial registration ClinicalTrials.gov identifier NCT02162017; ANZCTR identifier ACTRN12614000483651

scholarly journals Outcome of endovascular treatment within and beyond 6 h without perfusion software

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Zhen Jing ◽  
Hao Li ◽  
Shengming Huang ◽  
Min Guan ◽  
Yongxin Li ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Endovascular Treatment ◽  
General Anesthesia ◽  
Acute Ischemic Stroke ◽  
Clinical Outcomes ◽  
Symptom Onset ◽  
Anterior Circulation ◽  
Vessel Occlusion ◽  
Group A ◽  
Group B

AbstractEndovascular treatment (EVT) has been accepted as the standard of care for patients with acute ischemic stroke. The aim of the present study was to compare clinical outcomes of patients who received EVT within and beyond 6 h from symptom onset to groin puncture without perfusion software in Guangdong district, China. Between March 2017 and May 2018, acute ischemic stroke patients who received EVT from 6 comprehensive stroke centers, were enrolled into the registry study. In this subgroup study, we included all patients who had acute proximal large vessel occlusion in the anterior circulation. The demographic, clinical and neuroimaging data were collected from each center. A total of 192 patients were included in this subgroup study. They were divided into two groups: group A (n = 125), within 6 h; group B (n = 67), 6–24 h from symptom onset to groin puncture. There were no substantial differences between these two groups in terms of 90 days favorable outcome (modified Rankin scale [mRS] ≤ 2, P = 0.051) and mortality (P = 0.083), and the risk of symptomatic intracranial hemorrhage at 24 h (P = 0.425). The NIHSS (median 16, IQR12-20, group A; median 12, IQR8-18, group B; P = 0.009) and ASPECTS (median 10, IQR8-10, group A; median 9, IQR8-10, group B; P = 0.034) at baseline were higher in group A. The anesthesia method (general anesthesia, 21.3%, group A vs. 1.5% group B, P = 0.001) were also statistically different between the two groups. The NIHSS and ASPECTS were higher, and general anesthesia was also more widely used in group A. Clinical outcomes were not significantly different within 6 h versus 6–24 h from symptom onset to groin puncture in this real world study.

scholarly journals Statistical analysis plan for the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) trial: a randomized controlled trial of a specialist palliative care intervention for patients undergoing surgery for cancer

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Onur M. Orun ◽  
Myrick C. Shinall ◽  
Aimee Hoskins ◽  
Ellis Morgan ◽  
Mohana Karlekar ◽  
...  
Keyword(s):  
Palliative Care ◽  
Randomized Controlled Trial ◽  
Statistical Analysis ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Specialist Palliative Care ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Scope Trial

Abstract Background The impact of specialist palliative care intervention in patients undergoing surgery for cancer has not been studied extensively. The SCOPE randomized controlled trial will investigate the effect of specialist palliative care intervention in cancer patients undergoing surgery for selected abdominal malignancies. The study protocol of the SCOPE Trial was published in December 2019. Methods and design The SCOPE Trial is a single-center, single-blind, prospective, randomized controlled trial that will investigate specialist palliative care intervention for cancer patients undergoing surgery for selected abdominal malignancies. The study plans to enroll 236 patients that will be randomized to specialist palliative care (intervention arm) and usual care (control arm) in a 1:1 ratio. Results The primary outcome of the study is the Functional Assessment of Cancer Therapy-General (FACT-G) Trial Outcome Index (TOI) at 90 days postoperatively. Secondary outcomes of the study include the total FACT-G score at 90 days postoperatively, days alive at home without an emergency room visit within 90 days of operation, and all-cause mortality at 1 year after operation. Time frames for all outcomes will start on the day of surgery. Conclusion This manuscript serves as the formal statistical analysis plan (version 1.0) for the SCOPE randomized controlled trial. The statistical analysis plan was completed on 6 April 2021. Trial registration ClinicalTrials.gov NCT03436290. Registered on 16 February 2018

Abstract 181: Determinants of Intracranial Atherosclerotic Enhancement on Vessel Wall MRI in Patients with Acute Ischemic Stroke

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Adam de Havenon ◽  
Nabeel Chauhan ◽  
Jennifer Majersik ◽  
David Tirschwell ◽  
Ka-Ho Wong ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Vessel Wall ◽  
Recurrent Stroke ◽  
Pulse Sequences ◽  
High Rate ◽  
Stroke Recurrence ◽  
Anterior Circulation ◽  
Post Contrast

Introduction: Enhancing intracranial atherosclerotic plaque on high-resolution vessel wall MRI (vwMRI) is a reliable marker of recent thromboembolism, and confers a recurrent stroke risk of up to 30% a year. Post-contrast plaque enhancement (PPE) on vwMRI is thought to represent inflammation, but studies have not fully examined the clinical, serologic or radiologic factors that contribute to PPE. Methods: Inpatients with acute ischemic stroke due to intracranial atherosclerosis were prospectively enrolled at a single center from 2015-16. vwMRI was performed on a 3T Siemens Verio and included 3D DANTE pulse sequences, pre- and post-contrast (for PPE identification). Three experienced neuroradiologists interpreted vwMRI using a validated multicontrast technique. The Chi-squared, Fisher’s Exact, and Student’s t-test were used for intergroup differences, and logistic regression was fitted to the primary outcome of PPE. Results: Inclusion criteria were met by 35 patients. Atherosclerotic plaques were in the anterior circulation in 21/35 (60%) and PPE was diagnosed in 20/35 (57%) of stroke parent arteries. PPE predictors are shown in Table 1 with logistic regression in Table 2 . Conclusion: PPE is associated with stenosis, which was expected, but the association with HgbA1c is novel. All patients with HgbA1c >8 had PPE and a one point HgbA1c rise increased the odds of PPE 3-fold. Hyperglycemia induces vascular oxidative stress by generating reactive oxygen species, quenching nitric oxide, and triggering an inflammatory cascade. Given the high rate of stroke recurrence in PPE patients, aggressive HgbA1c reduction may be a viable treatment target and warrants additional study.

A Pilot Study of Nicardipine for Acute Ischemic Stroke. The Nicardipine Study Group

1989 ◽  
pp. 367-372 ◽  
Author(s):  
D. M. Rosenbaum ◽  
J. C. Grotta ◽  
F. M. Yatsu ◽  
C. M. Picone ◽  
L. C. Pettigrew ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Pilot Study ◽  
Acute Ischemic Stroke ◽  
Study Group
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