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New care bundle aims to save lives after brain hemorrhage

NCT ID NCT06429332

Disease control Sponsor: Region Skane Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a structured care bundle—including rapid blood pressure control, reversal of blood thinners, and management of fever and blood sugar—can improve outcomes for people with a brain bleed. About 3500 adults in Sweden and Australia will receive either the care bundle or standard care. The goal is to see if this approach reduces disability and improves quality of life at 3 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
care bundle (blood pressure lowering, anticoagulation reversal, fever and glucose management)
What this could lead to
If successful, this care bundle could become a standard treatment to improve recovery and reduce disability after a brain bleed.
What could go wrong
This is a large trial, but the care bundle involves multiple steps, so it may be hard to implement consistently. Results may not apply to all settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 3,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults (age ≥18 years) * Non-contrast computerized tomography (NCCT) imaging-verified diagnosis of spontaneous intracerebral haemorrhage * ≤24 hours from symptom onset or presumed symptom onset (last seen well) Exclusion Criteria: * Previous care limitation * End-stage comorbidity with short life-expectancy (\<6 m; e.g. terminal cancer) * ICH caused by brain tumor or cerebral venous thrombosis * Clinical signs of brain herniation at first presentation (unresponsive patient with bilaterally fixed, maximally dilated pupils) * Pregnant women beyond 22 weeks gestation may only be included after thorough discussion with an obstetrician to determine risks vs benefit.

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Conditions

The condition(s) this trial relates to.

cerebrovascular disorder intracerebral hemorrhage stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cerebrovascular disease Intracerebral haemorrhage Intracerebral hemorrhage Intraventricular hemorrhage Stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    54 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Akademiska Sjukhuset Uppsal

    RECRUITING

    Uppsala, 75185, Sweden

  • Avezzano Ospedale SS. Filippo e Nicola

    RECRUITING

    Avezzano, 67051, Italy

  • Azienda Ospedaliera Santa Maria della Misericordia Perugia

    RECRUITING

    Perugia, 06129, Italy

  • Blekingesjukhuset

    RECRUITING

    Karlskrona, Sweden

  • Blekingesjukhuset Karlskrona

    RECRUITING

    Karlskrona, 371 41, Sweden

  • Capio St Görans Sjukhus

    RECRUITING

    Stockholm, 112 81, Sweden

  • Centrallasarettet Växjö

    RECRUITING

    Vaxjo, Sweden

  • Centralsjukhuset Karlstad

    RECRUITING

    Karlstad, 651 85, Sweden

  • Centralsjukhuset Kristianstad

    RECRUITING

    Kristianstad, Sweden

  • Citta di Castello Ospedale Città di Castello

    RECRUITING

    Città di Castello, 06012, Italy

  • Danderyds sjukhus

    RECRUITING

    Stockholm, 182 88, Sweden

  • Gubbio Ospedale di Gubbio e Gualdo Tadino

    RECRUITING

    Gubbio, Italy, Italy

  • Hallands sjukhus Varberg

    RECRUITING

    Varberg, 43237, Sweden

  • Hamilton General Hospital

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Health Sciences North/Health Sciences North Research Institute

    RECRUITING

    Greater Sudbury, Ontario, P3E 5J1, Canada

  • Helsingborgs Lasarett

    RECRUITING

    Helsingborg, Sweden

  • Hong Kong University Hospital

    RECRUITING

    Hong Kong, Hong Kong

  • Hässleholms Sjukhus

    RECRUITING

    Hässleholm, Sweden

  • Höglandssjukhuset i Eksjö

    RECRUITING

    Eksjö, 575 81, Sweden

  • Karolinska Universitetssjukhuset Huddinge

    RECRUITING

    Huddinge, Sweden

  • Karolinska Universitetssjukhuset Solna

    RECRUITING

    Stockholm, 171 76, Sweden

  • Kungälvs sjukhus

    RECRUITING

    Kungälv, 442 83, Sweden

  • Landspitali University Hospital

    RECRUITING

    Reykjavik, 105, Iceland

  • Lasarettet i Enköping

    RECRUITING

    Uppsala, 751 85, Sweden

  • Ljungby Lasarett

    RECRUITING

    Ljungby, 341 35, Sweden

  • Länssjukhuset Kalmar

    RECRUITING

    Kalmar, 391 85, Sweden

  • Länssjukhuset Ryhov

    RECRUITING

    Jönköping, 551 85, Sweden

  • Länssjukhuset Sundsvall

    RECRUITING

    Sundsvall, Sweden

  • Monash Medical Centre

    RECRUITING

    Clayton, 3168, Australia

  • Mölndals Sjukhus

    RECRUITING

    Mölndal, 431 80, Sweden

  • National University of Malaysia Hospital

    RECRUITING

    Kuala Lumpur, 56000, Malaysia

  • Norra Älvsborgs Länssjukhus

    RECRUITING

    Trollhättan, 461 85, Sweden

  • Norrlands Universitetssjukhus

    RECRUITING

    Umeå, Sweden

  • Oskarshamn Sjukhus

    RECRUITING

    Oskarshamn, 572 28, Sweden

  • Ottawa Hospital Research Institute

    RECRUITING

    Ottawa, Ontario, K1Y 4E9, Canada

  • Region Skåne, Skåne University Hospital in Malmö, Department of Neurology

    RECRUITING

    Malmö, 20502, Sweden

  • Roma Policlinico Gemelli

    RECRUITING

    Roma, 00136, Italy

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, 5000, Australia

  • Sahlgrenska Universitetssjukhuset

    RECRUITING

    Gothenburg, 413 45, Sweden

  • Skaraborgs Sjukhus Skövde

    RECRUITING

    Skövde, 541 85, Sweden

  • Skåne University Hospital Lund

    RECRUITING

    Lund, Sweden

  • Skåne University Hospital Lund Neurosurgery dept

    RECRUITING

    Lund, Sweden

  • Södersjukhuset

    RECRUITING

    Stockholm, 118 83, Sweden

  • The George Institute for Global Health

    NOT_YET_RECRUITING

    Sydney, NSW 2000, Australia

  • The University of Oklahoma Health

    RECRUITING

    Oklahoma City, Oklahoma, 73126-0901, United States

  • Univeristetssjukhuset Linköping

    RECRUITING

    Linköping, 581 85, Sweden

  • Universitetssjukhuset Örebro

    RECRUITING

    Örebro, 701 85, Sweden

  • Universiti Putra Malaysia Hospital

    RECRUITING

    Serdang, 43400, Malaysia

  • Värnamo sjukhus

    RECRUITING

    Värnamo, 331 85, Sweden

  • Västerås

    RECRUITING

    Västerås, 721 89, Sweden

  • Västmanlands sjukhus Köping

    RECRUITING

    Köping, 731 81, Sweden

  • Ystads lasarett

    RECRUITING

    Ystad, Sweden

  • Östersunds Lasarett

    RECRUITING

    Östersund, Sweden

  • Östra Sjukhuset

    RECRUITING

    Gothenburg, 41685, Sweden

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