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| ID | Type | Description | Link |
|---|---|---|---|
| HIPS/22/36 | Other Grant/Funding Number | Chief Scientist Office of the Scottish Government | |
| 325272 | Other Identifier | Integrated Research Application System |
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| Name | Class |
|---|---|
| University of the West of Scotland | OTHER |
| University of Nottingham | OTHER |
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The goal of this observational study is to answer three uncertainties about the design of a platform study for adults with stroke due to intracerebral haemorrhage.
The main things the investigators aim to find out are:
Participants, or their welfare guardian, welfare attorney, or nearest relative will:
Background: Clinical trials have not found a treatment that works specifically for stroke caused by bleeding in the brain, known as intracerebral haemorrhage (ICH for short). Most clinical trials have studied one treatment at a time and included only 1 in 10 people with ICH. That's why each clinical trial recruited only 77 participants on average. A PLatform trial for INTracerebral Haemorrhage (PLINTH) will change this by investigating several treatments and giving everyone with ICH an opportunity to take part.
Aim: The investigators intend PLINTH to be large, inclusive, efficient and assess several treatments for ICH. First, a feasibility study is needed to work out whether PLINTH can succeed.
Methods: The investigators will find people recently diagnosed with ICH in Lothian and Lanarkshire and invite them to take part in a feasibility study. The investigators will provide them with personalised information using Tailored Talks. The investigators will find out if PLINTH is acceptable to people with ICH, carers, and doctors. The investigators will use data that are collected routinely to follow participants' progress. Characteristics and outcomes of participants will help design PLINTH.
Patient & public involvement: The investigators asked ICH survivors about PLINTH: 92% strongly agreed that working out how to do a platform study to find treatments for ICH is a priority. An ICH survivor is in the study team.
Dissemination: The investigators will produce easy access reports and share them with people with ICH, carers, healthcare professionals, and the public in their preferred format (printed, email, social media, and on the Research to Understand Stroke due to Haemorrhage website [http://www.RUSH.ed.ac.uk\ [blocked]]).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interview | Other | Semi-structured interview to assess understanding and acceptability at 3+/-2 and 14+/-7 days after consent |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | The frequency of people with incident ICH for whom there is at least one management uncertainty about ICH, with consent to participate in this feasibility study, and willingness to consider participating in a future PLINTH | 21 months |
| Measure | Description | Time Frame |
|---|---|---|
| Estimates required for the design of an inclusive and representative future PLINTH | Demographic and clinical characteristics of people incident with ICH who would participate in a future PLINTH | 21 months |
| Feasibility of the consent process |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with stroke due to intracerebral haemorrhage
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| Name | Affiliation | Role |
|---|---|---|
| Rustam AS Salman, MA PhD FRCPE | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Infirmary of Edinburgh | Edinburgh | City Of Edinburgh | EH16 4SA | United Kingdom | ||
| University Hospital Monklands |
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| Label | URL |
|---|---|
| Study website | View source |
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Once the data retention period is over, study data will be de-identified and archived in the University of Edinburgh's secure DataShare (https://datashare.ed.ac.uk/), an open access repository.
One year after completion of the study
Data collected or generated by the study may be transferred to any external individuals or organisations outside of the Sponsoring organisation(s) under a defined data sharing agreement.
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Acceptability to participants of an electronic approach to providing personalised information about their care and shared decision making about potential eligibility for recruitment to a future PLINTH (video abstract and Tailored Talks)
| 21 months |
| Airdrie |
| Lanarkshire |
| ML6 0JS |
| United Kingdom |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |