International Care Bundle Evaluation in Cerebral Hemorrhage Research

Recruiting now · Phase 4

Conditions studied: Intracerebral Hemorrhage, Intracerebral Haemorrhage, Intraventricular Hemorrhage, Stroke, Cerebrovascular Disease

In brief

Spontaneous intracerebral haemorrhage (ICH) accounts for approximately 10-15% of all strokes but stands for 50% of stroke-related morbidity and mortality. Approximately half of all patients with ICH have a decreased level of consciousness at hospital admission. Despite this, intensive care and neurosurgical interventions are uncommon. A study conducted in low- and middle-income countries has demonstrated a beneficial effect of a treatment package consisting of early intensive blood pressure lowering, as well as the treatment of pyrexia and elevated blood glucose levels. The I-CATCHER team is now planning to conduct a similar study in Sweden and Australia, as well as in other high-income countries. The study has a clear focus on implementation, aiming to improve treatment and prognosis for patients with ICH within a few years. The purpose of I-CATCHER is to investigate whether a structured treatment package (Care Bundle) improves 3-month prognosis in patients with spontaneous ICH compared to standard care.

Key facts

Study ID

NCT06429332

Run by

Region Skane

People needed

3500

Starts

2025-01-07

Expected to finish

2027-07-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• The University of Oklahoma Health — Oklahoma City, Oklahoma, United States (enrolling)
• Monash Medical Centre — Clayton, Australia (enrolling)
• Royal Adelaide Hospital — Adelaide, Australia (enrolling)
• Health Sciences North/Health Sciences North Research Institute — Greater Sudbury, Ontario, Canada (enrolling)
• Hamilton General Hospital — Hamilton, Ontario, Canada (enrolling)
• Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (enrolling)
• Hong Kong University Hospital — Hong Kong, Hong Kong (enrolling)
• Landspitali University Hospital — Reykjavik, Iceland (enrolling)
• Avezzano Ospedale SS. Filippo e Nicola — Avezzano, Italy (enrolling)
• Citta di Castello Ospedale Città di Castello — Città di Castello, Italy (enrolling)
• Gubbio Ospedale di Gubbio e Gualdo Tadino — Gubbio, Italy (enrolling)
• Azienda Ospedaliera Santa Maria della Misericordia Perugia — Perugia, Italy (enrolling)
• Roma Policlinico Gemelli — Roma, Italy (enrolling)
• National University of Malaysia Hospital — Kuala Lumpur, Malaysia (enrolling)
• Universiti Putra Malaysia Hospital — Serdang, Malaysia (enrolling)
• Höglandssjukhuset i Eksjö — Eksjö, Sweden (enrolling)
• Sahlgrenska Universitetssjukhuset — Gothenburg, Sweden (enrolling)
• Östra Sjukhuset — Gothenburg, Sweden (enrolling)
• Hässleholms Sjukhus — Hässleholm, Sweden (enrolling)
• Helsingborgs Lasarett — Helsingborg, Sweden (enrolling)
• Karolinska Universitetssjukhuset Huddinge — Huddinge, Sweden (enrolling)
• Länssjukhuset Ryhov — Jönköping, Sweden (enrolling)
• Länssjukhuset Kalmar — Kalmar, Sweden (enrolling)
• Blekingesjukhuset Karlskrona — Karlskrona, Sweden (enrolling)
• Blekingesjukhuset — Karlskrona, Sweden (enrolling)

Full record on ClinicalTrials.gov

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