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Author Ker, Katharine ♦ Sprigg, Nikola ♦ Mahmood, Abda ♦ Prietomerino, David ♦ Bath, Philip ♦ Flaherty, Katie ♦ Law, Zhe Kang ♦ Roberts, Ian
Source Directory of Open Access Journals (DOAJ)
Content type Text
Publisher Wellcome
File Format HTM / HTML
Date Created 2018-02-26
Copyright Year ©2018
Language English
Subject Domain (in LCC) R ♦ Q
Subject Keyword Health Systems & Services Research ♦ Methods for Diagnostic & Therapeutic Studies ♦ Methods of Clinical Decision-Making ♦ Statistical Methodologies & Health Informatics ♦ Science ♦ Medicine
Abstract Introduction: The Antifibrinolytic Trialists Collaboration aims to increase knowledge about the effectiveness and safety of antifibrinolytic treatment by conducting individual patient data (IPD) meta-analyses of randomised trials. This article presents the statistical analysis plan for an IPD meta-analysis of the effects of antifibrinolytics for acute intracranial haemorrhage. Methods: The protocol for the IPD meta-analysis has been registered with PROSPERO (CRD42016052155). We will conduct an individual patient data meta-analysis of randomised controlled trials with 1000 patients or more assessing the effects of antifibrinolytics in acute intracranial haemorrhage. We will assess the effect on two co-primary outcomes: 1) Death in hospital within 30 days of randomisation, and 2) Death  or dependency at final follow-up within 90 days of randomisation. The co-primary outcomes will be limited to patients treated within three hours of injury or stroke onset. We will report treatment effects using odds ratios and 95% confidence intervals. We use logistic regression models to examine how the effect of antifibrinolytics vary by time to treatment, severity of intracranial bleeding, and age. We will also examine the effect of antifibrinolytics on secondary outcomes including death, dependency, vascular occlusive events, seizures, and neurological outcomes. Secondary outcomes will be assessed in all patients irrespective of time of treatment. All analyses will be conducted on an intention-to-treat basis. Conclusions: This IPD meta-analysis will examine important clinical questions about the effects of antifibrinolytic treatment in patients with intracranial haemorrhage that cannot be answered using aggregate data. With IPD we can examine how effects vary by time to treatment, bleeding severity, and age, to gain better understanding of the balance of benefit and harms on which to base recommendations for practice.
ISSN 2398502X
Age Range 18 to 22 years ♦ above 22 year
Educational Use Research
Education Level UG and PG ♦ Career/Technical Study
Learning Resource Type Article
Publisher Date 2018-02-01
e-ISSN 2398502X
Journal Wellcome Open Research
Volume Number 2


Source: Directory of Open Access Journals (DOAJ)