Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT06078020
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-03
First Post:
2023-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PLatform Study for INTracerebral Haemorrhage (PLINTH): Community-based Feasibility Study
Sponsor:
University of Edinburgh
Organization:
Study Overview
Official Title:
PLatform Study for INTracerebral Haemorrhage (PLINTH): Community-based Feasibility Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLINTH
Brief Summary:
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:
* The acceptability of a platform trial and its comparisons to brain haemorrhage survivors or their carers, and their clinicians.
* Estimates of eligibility, willingness to participate, diversity, representativeness, adherence, retention, data completion, and event rates of intermediate and clinical outcomes over time for each comparison.
* The most efficient platform trial design considering the findings of this feasibility study.
Participants, or their welfare guardian, welfare attorney, or nearest relative will:
* Watch a video informing them about the study
* Read written information about the study
* Provide informed consent
* Permit collection of demographic and clinical details
* Provide information in interviews at \~3 and \~14 days after the onset of the stroke
The main things the investigators aim to find out are:
* The acceptability of a platform trial and its comparisons to brain haemorrhage survivors or their carers, and their clinicians.
* Estimates of eligibility, willingness to participate, diversity, representativeness, adherence, retention, data completion, and event rates of intermediate and clinical outcomes over time for each comparison.
* The most efficient platform trial design considering the findings of this feasibility study.
Participants, or their welfare guardian, welfare attorney, or nearest relative will:
* Watch a video informing them about the study
* Read written information about the study
* Provide informed consent
* Permit collection of demographic and clinical details
* Provide information in interviews at \~3 and \~14 days after the onset of the stroke
Detailed Description:
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 \[http://www.RUSH.ed.ac.uk\]).
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 \[http://www.RUSH.ed.ac.uk\]).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: