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NCT06429332 · ClinicalTrials.gov registry record · Phase 4

International Care Bundle Evaluation in Cerebral Hemorrhage Research

A Phase 4 study of Stroke and Intracerebral Hemorrhage, sponsored by Region Skane.

Recruiting
Registry status
Phase 4
Development phase
3,500
Enrollment target
20
Study locations

NCT06429332: Recruiting Phase 4 study of Stroke and Intracerebral Hemorrhage, sponsored by Region Skane.

NCT06429332 is a Phase 4 study of Stroke and Intracerebral Hemorrhage that is actively recruiting participants, run by Region Skane. The registered enrollment target is 3,500 participants, below the 12,009-participant average among 454 other Stroke trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06429332, a Phase 4 study of Stroke and Intracerebral Hemorrhage, is actively recruiting participants, sponsored by Region Skane.

RECRUITING
Registry status
Phase 4
Development phase
3,500 participants
Enrollment target
20
Study locations

Study Summary

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.

Primary Outcome

The modified Rankin Scale (mRS) is an efficient, reliable, and simple functional outcome measure widely used as a primary endpoint in clinical trials for acute stroke. However, being an ordered categorical scale, it may not reflect potentially unequal differences in perceived quality of life associated with certain 1-point shifts vs others. Utility-weighted mRS is a score that weighs the mRS against a health utility scale, which defined as the desirability of a specific health outcome, facilitat

Interventions

  • OTHER Reversal of Oral anticoagulation within 30 minutes
  • OTHER Early intensive blood pressure lowering
  • OTHER Treatment of pyrexia
  • OTHER Hyperglycemia treatment
  • OTHER Do-not-resuscitate (DNR) or withdrawal of care

Study Locations (20)

Other

  • Royal Adelaide Hospital - Adelaide
  • Monash Medical Centre - Clayton
  • The George Institute for Global Health - Sydney
  • Hong Kong University Hospital - Hong Kong
  • Landspitali University Hospital - Reykjavik
  • Avezzano Ospedale SS. Filippo e Nicola - Avezzano
  • Citta di Castello Ospedale Città di Castello - Città di Castello
  • Gubbio Ospedale di Gubbio e Gualdo Tadino - Gubbio
  • Azienda Ospedaliera Santa Maria della Misericordia Perugia - Perugia
  • Roma Policlinico Gemelli - Roma
  • National University of Malaysia Hospital - Kuala Lumpur
  • Universiti Putra Malaysia Hospital - Serdang
  • Höglandssjukhuset i Eksjö - Eksjö
  • Sahlgrenska Universitetssjukhuset - Gothenburg
  • Östra Sjukhuset - Gothenburg
  • Hässleholms Sjukhus - Hässleholm
  • Helsingborgs Lasarett - Helsingborg
  • Karolinska Universitetssjukhuset Huddinge - Huddinge

Oklahoma

  • The University of Oklahoma Health - Oklahoma City

Ontario

  • Ottawa Hospital Research Institute - Ottawa

Trial Details

FieldValue
Enrollment Target 3,500 participants
Start Date 2025-01-07
Est. Completion 2027-07
Phase Phase 4
Region Skane

1 total trials

What NCT06429332 shows while recruiting

NCT06429332 is an interventional study that assigns participants to a tested intervention. Its 3,500 participants enrollment target places it among the larger protocols in the corpus, below the 12,009-participant average among 454 other Stroke trials with a reported enrollment target (71% lower).

The record links to 5 conditions, with Stroke appearing as the primary indexed condition, and to 5 interventions - of which Reversal of Oral anticoagulation within 30 minutes is the first listed.

NCT06429332 names 20 study sites across 3 states, led by Other, Oklahoma, Ontario.

Frequently Asked Questions

What is clinical trial NCT06429332 about?

NCT06429332 is a clinical study titled "International Care Bundle Evaluation in Cerebral Hemorrhage Research". 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 neuro...

What is the current status of trial NCT06429332?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 3,500 participants. The study started on 2025-01-07. Estimated completion is 2027-07.

What conditions does trial NCT06429332 study?

This clinical trial studies the following conditions: Stroke, Intracerebral Hemorrhage, Intraventricular Hemorrhage, Cerebrovascular Disease, Intracerebral Haemorrhage.

What interventions are being tested in trial NCT06429332?

The interventions under investigation include: Reversal of Oral anticoagulation within 30 minutes (OTHER), Early intensive blood pressure lowering (OTHER), Treatment of pyrexia (OTHER), Hyperglycemia treatment (OTHER), Do-not-resuscitate (DNR) or withdrawal of care (OTHER).

Who is sponsoring clinical trial NCT06429332?

This trial is sponsored by Region Skane, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06429332 being conducted?

This trial has 20 study locations across Oklahoma, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Stroke

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06429332's enrollment target sits among peer trials

3,500 19th of 454 higher than 436 of 454 other Stroke trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06429332, the US trial registry maintained by the National Library of Medicine. NCT06429332 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.