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Statistical reanalysis of vascular event outcomes in primary and secondary vascular prevention trials (2021)
Journal Article
Woodhouse, L. J., Montgomery, A. A., Mant, J., Davis, B. R., Algra, A., Mas, J.-L., …Bath, P. M. (2021). Statistical reanalysis of vascular event outcomes in primary and secondary vascular prevention trials. BMC Medical Research Methodology, 21, Article 218. https://doi.org/10.1186/s12874-021-01388-6

Background: Vascular prevention trials typically use dichotomous event outcomes although this may be inefficient statistically and gives no indication of event severity. We assessed whether ordinal outcomes would be more efficient and how to best ana... Read More about Statistical reanalysis of vascular event outcomes in primary and secondary vascular prevention trials.

Tranexamic Acid for Prevention of Hematoma Expansion in Intracerebral Hemorrhage Patients With or Without Spot Sign (2021)
Journal Article
Ovesen, C., Jakobsen, J. C., Gluud, C., Steiner, T., Law, Z., Flaherty, K., …Christensen, H. (2021). Tranexamic Acid for Prevention of Hematoma Expansion in Intracerebral Hemorrhage Patients With or Without Spot Sign. Stroke, 52(8), 2629-2636. https://doi.org/10.1161/strokeaha.120.032426

Background and Purpose: The computed tomography angiography or contrast-enhanced computed tomography based spot sign has been proposed as a biomarker for identifying on-going hematoma expansion in patients with acute intracerebral hemorrhage. We inv... Read More about Tranexamic Acid for Prevention of Hematoma Expansion in Intracerebral Hemorrhage Patients With or Without Spot Sign.

Quantitative CT radiomics-based models for prediction of haematoma expansion and poor functional outcome in primary intracerebral haemorrhage (2021)
Journal Article
Pszczolkowski, S., Manzano-Patron, J. P., Law, Z. K., Krishnan, K., Ali, A., Bath, P. M., …Dineen, R. A. (2021). Quantitative CT radiomics-based models for prediction of haematoma expansion and poor functional outcome in primary intracerebral haemorrhage. European Radiology, 31, 7945-7959. https://doi.org/10.1007/s00330-021-07826-9

Objectives To test radiomics-based features extracted from noncontrast CT of patients with spontaneous intracerebral haemorrhage for prediction of haematoma expansion and poor functional outcome and compare them with radiological signs and clinica... Read More about Quantitative CT radiomics-based models for prediction of haematoma expansion and poor functional outcome in primary intracerebral haemorrhage.

Outcomes in Antiplatelet‐Associated Intracerebral Hemorrhage in the TICH‐2 Randomized Controlled Trial (2021)
Journal Article
Law, Z. K., Desborough, M., Roberts, I., Al‐Shahi Salman, R., England, T. J., Werring, D. J., …Sprigg, N. (2021). Outcomes in Antiplatelet‐Associated Intracerebral Hemorrhage in the TICH‐2 Randomized Controlled Trial. Journal of the American Heart Association, 10(5), Article e019130. https://doi.org/10.1161/jaha.120.019130

Background Antiplatelet therapy increases the risk of hematoma expansion in intracerebral hemorrhage (ICH) while the effect on functional outcome is uncertain. Methods and Results This is an exploratory analysis of the TICH‐2 (Tranexamic Acid in... Read More about Outcomes in Antiplatelet‐Associated Intracerebral Hemorrhage in the TICH‐2 Randomized Controlled Trial.

Corrigendum: Intracranial Bleeding After Reperfusion Therapy in Acute Ischaemic Stroke Patients Randomized to Glyceryl Trinitrate vs. Control: An Individual Patient Data Meta-Analysis (2020)
Journal Article
Appleton, J. P., Woodhouse, L. J., Sprigg, N., Wardlaw, J. M., & Bath, P. M. (2020). Corrigendum: Intracranial Bleeding After Reperfusion Therapy in Acute Ischaemic Stroke Patients Randomized to Glyceryl Trinitrate vs. Control: An Individual Patient Data Meta-Analysis. Frontiers in Neurology, 11, Article 625572. https://doi.org/10.3389/fneur.2020.625572

Joanna M. Wardlaw was not included as an author in the published article. The corrected Author Contributions and Funding statements appear below. AUTHOR CONTRIBUTIONS JA performed the literature search, pooled analyses, statistical analysis and inter... Read More about Corrigendum: Intracranial Bleeding After Reperfusion Therapy in Acute Ischaemic Stroke Patients Randomized to Glyceryl Trinitrate vs. Control: An Individual Patient Data Meta-Analysis.

Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH): protocol for a phase II double blind randomised controlled feasibility trial (2020)
Journal Article
Desborough, M. J., Al-Shahi Salman, R., Stanworth, S. J., Havard, D., Brennan, P. M., Dineen, R. A., …DASH trial investigators. (2020). Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH): protocol for a phase II double blind randomised controlled feasibility trial. BMJ Open, 10(11), Article e037555. https://doi.org/10.1136/bmjopen-2020-037555

Introduction Intracerebral haemorrhage (ICH) can be devastating and is a common cause of death and disability worldwide. Pre-ICH antiplatelet drug use is associated with a 27% relative increase in 1 month case fatality compared with patients not usin... Read More about Desmopressin for reversal of Antiplatelet drugs in Stroke due to Haemorrhage (DASH): protocol for a phase II double blind randomised controlled feasibility trial.

Relationship between nitrate headache and outcome in patients with acute stroke: results from the efficacy of nitric oxide in stroke (ENOS) trial (2020)
Journal Article
Beishon, L., Woodhouse, L. J., Bereczki, D., Christensen, H. K., Collins, R., Gommans, J., …Bath, P. M. (2021). Relationship between nitrate headache and outcome in patients with acute stroke: results from the efficacy of nitric oxide in stroke (ENOS) trial. Stroke and Vascular Neurology, 6(2), 180-186. https://doi.org/10.1136/svn-2020-000498

Introduction Nitrate-induced headache is common and may signify responsive cerebral vasculature. We assessed the relationship between nitrate headache and outcome in patients with acute stroke. Materials and methods Patients were those randomised to... Read More about Relationship between nitrate headache and outcome in patients with acute stroke: results from the efficacy of nitric oxide in stroke (ENOS) trial.

Intracranial Bleeding After Reperfusion Therapy in Acute Ischaemic Stroke Patients Randomized to Glyceryl Trinitrate vs. Control: An Individual Patient Data Meta-Analysis (2020)
Journal Article
Appleton, J. P., Woodhouse, L. J., Sprigg, N., Wardlaw, J. M., & Bath, P. M. (2020). Intracranial Bleeding After Reperfusion Therapy in Acute Ischaemic Stroke Patients Randomized to Glyceryl Trinitrate vs. Control: An Individual Patient Data Meta-Analysis. Frontiers in Neurology, 11, Article 584038. https://doi.org/10.3389/fneur.2020.584038

Background: Thrombolysis, with or without thrombectomy, for acute ischaemic stroke is associated with an increased risk of intracranial bleeding. We assessed whether treatment with glyceryl trinitrate (GTN), a nitric oxide donor, may influence the as... Read More about Intracranial Bleeding After Reperfusion Therapy in Acute Ischaemic Stroke Patients Randomized to Glyceryl Trinitrate vs. Control: An Individual Patient Data Meta-Analysis.

Rates, risks and routes to reduce vascular dementia (R4vad), a UK-wide multicentre prospective observational cohort study of cognition after stroke: Protocol (2020)
Journal Article
Wardlaw, J. M., Doubal, F., Brown, R., Backhouse, E., Woodhouse, L., Bath, P., …R4VaD Investigators. (2021). Rates, risks and routes to reduce vascular dementia (R4vad), a UK-wide multicentre prospective observational cohort study of cognition after stroke: Protocol. European Stroke Journal, 6(1), 89-101. https://doi.org/10.1177/2396987320953312

Background: Stroke commonly affects cognition and, by definition, much vascular dementia follows stroke. However, there are fundamental limitations in our understanding of vascular cognitive impairment, restricting understanding of prevalence, trajec... Read More about Rates, risks and routes to reduce vascular dementia (R4vad), a UK-wide multicentre prospective observational cohort study of cognition after stroke: Protocol.

Predictors and outcomes of neurological deterioration in intracerebral hemorrhage: results from the TICH-2 randomised controlled trial (2020)
Journal Article
Kang Law, Z., Dineen, R., England, T. J., Cala, L., Mistri, A. K., Appleton, J. P., …TICH-2 investigators. (2021). Predictors and outcomes of neurological deterioration in intracerebral hemorrhage: results from the TICH-2 randomised controlled trial. Translational Stroke Research, 12, 275-283. https://doi.org/10.1007/s12975-020-00845-6

Neurological deterioration is common after intracerebral hemorrhage (ICH). We aimed to identify the predictors and effects of neurological deterioration and whether tranexamic acid reduced the risk of neurological deterioration. Data from the Tranexa... Read More about Predictors and outcomes of neurological deterioration in intracerebral hemorrhage: results from the TICH-2 randomised controlled trial.

Developing a Fatigue Programme: Protocol for the Nottingham Fatigue After Stroke (NotFAST2) (2020)
Journal Article
Drummond, A., Ablewhite, J., Condon, L., das Nair, R., Jones, A., Jones, F., …Thomas, S. (2020). Developing a Fatigue Programme: Protocol for the Nottingham Fatigue After Stroke (NotFAST2). British Journal of Occupational Therapy, 83(11), 674-679. https://doi.org/10.1177/0308022620944797

Introduction Post-stroke fatigue is common and is one of the most distressing symptoms after stroke. It has a negative impact on physical, social and psychological functioning; it is also associated with poor outcomes and increased mortality. The... Read More about Developing a Fatigue Programme: Protocol for the Nottingham Fatigue After Stroke (NotFAST2).

Developing a fatigue programme: Protocol for the Nottingham Fatigue After Stroke (NotFAST2) study (2020)
Journal Article
Drummond, A., Ablewhite, J., Condon, L., Nair, R. D., Jones, A., Jones, F., …Thomas, S. (2020). Developing a fatigue programme: Protocol for the Nottingham Fatigue After Stroke (NotFAST2) study. British Journal of Occupational Therapy, 83(11), 674-679. https://doi.org/10.1177/0308022620944797

Introduction: Post-stroke fatigue (PSF) is common and is one of the most distressing symptoms after stroke. It has a negative impact on physical, social and psychological functioning: it is also associated with poor outcomes and increased mortality.... Read More about Developing a fatigue programme: Protocol for the Nottingham Fatigue After Stroke (NotFAST2) study.

Optimising Psychoeducation for Transient Ischaemic Attack and Minor Stroke Management (OPTIMISM): Protocol for a feasibility randomised controlled trial (2020)
Journal Article
Kontou, E., Walker, M., Thomas, S., Watkins, C., Griffiths, H., Golding-Day, M., …Sprigg, N. (2020). Optimising Psychoeducation for Transient Ischaemic Attack and Minor Stroke Management (OPTIMISM): Protocol for a feasibility randomised controlled trial. AMRC Open Research, 2, Article 24. https://doi.org/10.12688/amrcopenres.12911.1

Background: A transient ischaemic attack (TIA) and minor stroke are medical emergencies and often a warning sign of future strokes if remain untreated. Few studies have investigated the long-term psychosocial effects of TIA and minor stroke. Secondar... Read More about Optimising Psychoeducation for Transient Ischaemic Attack and Minor Stroke Management (OPTIMISM): Protocol for a feasibility randomised controlled trial.

Real-world Independent Testing of e-ASPECTS Software (RITeS): statistical analysis plan (2020)
Journal Article
Mair, G., Chappell, F., Martin, C., Dye, D., Bath, P. M., Muir, K. W., …Wardlaw, J. M. (2020). Real-world Independent Testing of e-ASPECTS Software (RITeS): statistical analysis plan. AMRC Open Research, 2, Article 20. https://doi.org/10.12688/amrcopenres.12904.1

Background: Artificial intelligence-based software may automatically detect ischaemic stroke lesions and provide an Alberta Stroke Program Early CT score (ASPECTS) on CT, and identify arterial occlusion and provide a collateral score on CTA. Large-sc... Read More about Real-world Independent Testing of e-ASPECTS Software (RITeS): statistical analysis plan.

Protocol: The Lacunar Intervention Trial 2 (LACI-2). A trial of two repurposed licenced drugs to prevent progression of cerebral small vessel disease (2020)
Journal Article
Wardlaw, J., Bath, P. M., Doubal, F., Heye, A., Sprigg, N., Woodhouse, L. J., …The LACI-2 Trial Investigators. (2020). Protocol: The Lacunar Intervention Trial 2 (LACI-2). A trial of two repurposed licenced drugs to prevent progression of cerebral small vessel disease. European Stroke Journal, 5(3), 297-308. https://doi.org/10.1177/2396987320920110

Background Small vessel disease causes a quarter of ischaemic strokes (lacunar subtype), up to 45% of dementia either as vascular or mixed types, cognitive impairment and physical frailty. However, there is no specific treatment to prevent progressi... Read More about Protocol: The Lacunar Intervention Trial 2 (LACI-2). A trial of two repurposed licenced drugs to prevent progression of cerebral small vessel disease.

Intracerebral implantation of human neural stem cells and motor recovery after stroke: multicentre prospective single-arm study (PISCES-2) (2020)
Journal Article
Muir, K. W., Bulters, D., Willmot, M., Sprigg, N., Dixit, A., Ward, N., …Sinden, J. (2020). Intracerebral implantation of human neural stem cells and motor recovery after stroke: multicentre prospective single-arm study (PISCES-2). Journal of Neurology, Neurosurgery and Psychiatry, 91(4), 396-401. https://doi.org/10.1136/jnnp-2019-322515

Background Human neural stem cell implantation may offer improved recovery from stroke. We investigated the feasibility of intracerebral implantation of the allogeneic human neural stem cell line CTX0E03 in the subacute—chronic recovery phase of... Read More about Intracerebral implantation of human neural stem cells and motor recovery after stroke: multicentre prospective single-arm study (PISCES-2).

Elevated plasminogen activators are associated with hematoma progression in spontaneous intracerebral hemorrhage (2020)
Journal Article
Law, Z. K., Desborough, M., Rakkar, K., Bath, P. M., Bayraktutan, U., & Sprigg, N. (2020). Elevated plasminogen activators are associated with hematoma progression in spontaneous intracerebral hemorrhage. Brain Hemorrhages, 1(1), 75-79. https://doi.org/10.1016/j.hest.2019.12.001

Endogenous fibrinolysis might lead to hematoma progression in spontaneous intracerebral hemorrhage (ICH). We studied plasma biomarkers of fibrinolysis and hemostasis in twenty-two patients with ICH and nine healthy controls (HC) in a single-center st... Read More about Elevated plasminogen activators are associated with hematoma progression in spontaneous intracerebral hemorrhage.

Tranexamic acid to improve functional status in adults with spontaneous intracerebral haemorrhage: the TICH-2 RCT (2019)
Journal Article
Sprigg, N., Flaherty, K., Appleton, J. P., Al-Shahi Salman, R., Bereczki, D., Beridze, M., …Bath, P. M. (2019). Tranexamic acid to improve functional status in adults with spontaneous intracerebral haemorrhage: the TICH-2 RCT. Health Technology Assessment, 23(35), 1-48. https://doi.org/10.3310/hta23350

BACKGROUND: Tranexamic acid reduces death due to bleeding after trauma and postpartum haemorrhage. OBJECTIVE: The aim of the study was to assess if tranexamic acid is safe, reduces haematoma expansion and improves outcomes in adults with spontaneous... Read More about Tranexamic acid to improve functional status in adults with spontaneous intracerebral haemorrhage: the TICH-2 RCT.

The effectiveness and safety of anti-fibrinolytics in patients with acute intracranial haemorrhage: statistical analysis plan for an individual patient data meta-analysis [version 3; peer review: 2 approved] (2019)
Journal Article
Ker, K., Prieto-Merino, D., Sprigg, N., Mahmood, A., Bath, P., Kang Law, Z., …Roberts, I. (2019). The effectiveness and safety of anti-fibrinolytics in patients with acute intracranial haemorrhage: statistical analysis plan for an individual patient data meta-analysis [version 3; peer review: 2 approved]. Wellcome Open Research, Article 120. https://doi.org/10.12688/wellcomeopenres.13262.3

Introduction: The Anti-fibrinolytics Trialists Collaboration aims to increase knowledge about the effectiveness and safety of anti-fibrinolytic treatment by conducting individual patient data (IPD) meta-analyses of randomised trials. This article pre... Read More about The effectiveness and safety of anti-fibrinolytics in patients with acute intracranial haemorrhage: statistical analysis plan for an individual patient data meta-analysis [version 3; peer review: 2 approved].

Therapeutic hypothermia for acute ischaemic stroke. Results of a European multicentre, randomised, phase III clinical trial (2019)
Journal Article
van der Worp, H. B., Macleod, M. R., Bath, P. M., Bathula, R., Christensen, H., Colam, B., …the EuroHYP-1 investigators. (2019). Therapeutic hypothermia for acute ischaemic stroke. Results of a European multicentre, randomised, phase III clinical trial. European Stroke Journal, 4(3), 254-262. https://doi.org/10.1177/2396987319844690

© European Stroke Organisation 2019. Introduction: We assessed whether modest systemic cooling started within 6 hours of symptom onset improves functional outcome at three months in awake patients with acute ischaemic stroke. Patients and methods: In... Read More about Therapeutic hypothermia for acute ischaemic stroke. Results of a European multicentre, randomised, phase III clinical trial.