Recruiting

Care Bundle

Sponsor:

Region Skane

Code:

NCT06429332

Conditions

Intracerebral Hemorrhage

Intracerebral Haemorrhage

Intraventricular Hemorrhage

Stroke

Cerebrovascular Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Reversal of Oral anticoagulation within 30 minutes

Early intensive blood pressure lowering

Treatment of pyrexia

Hyperglycemia treatment

Do-not-resuscitate (DNR) or withdrawal of care

Study Details

Brief 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.

Conditions

Intracerebral Hemorrhage

Intracerebral Haemorrhage

Intraventricular Hemorrhage

Stroke

Cerebrovascular Disease

Study ID

NCT06429332

Start date

Jan 7, 2025

Status verified date

May, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

3500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intervention group

A range of implementation methods will be used to introduce an active Care Bundle with time- and target-based metrics that involve the rapid correction of abnormal physiological variables over days or hospital discharge (or death, if sooner) and referral pathways

placebo comparator: Usual care

For patients in the usual-care group, decisions about the location of care delivery, investigations, monitoring, and all treatments are made by the treating clinical team. Data will be collected regarding the management of patients, including insertion of invasive monitoring devices, intravenous fluid resuscitation, BP lowering, vasoactive support, glycemic control, mechanical ventilation, neurosurgery, and other supportive therapy.

Interventions

Reversal of Oral anticoagulation within 30 minutes

In situations of either an elevated INR with the use of warfarin - treatment with either 3- or 4-factor prothrombin complex concentrate (PCC) or fresh frozen plasma (FFP) within 30 minutes of ICH diagnosis on NCCT to reach and maintain an INR target <1.3; or where there has been recent use (<48 hours) of a direct oral anticoagulant (DOAC), use of an appropriate reversal agent within 30 minutes, where available, and according to local approvals.

Early intensive blood pressure lowering

A systolic blood pressure (BP) target of 130-140 mmHg within 30 minutes of ICH diagnosis on NCCT is strived for, and to maintain this BP level for the first 7 days (for patients presenting with blood pressure <200 mmHg). If blood pressure ≥200 and <220, a target BP of 160 mmHg should be targeted at 30 minutes, and 130-140 mmHg should be achieved in 60 minutes. If BP ≥220, target BP of 160 mmHg and should be achieved in 60 minutes.

Treatment of pyrexia

To achieve a body temperature target <37.5 °C within the first 24h following ICH diagnosis on NCCT

Hyperglycemia treatment

To maintain a blood glucose level 7-10 mmol/L within the first 24h following ICH diagnosis on NCCT

Do-not-resuscitate (DNR) or withdrawal of care

Refrain from the use of DNR or withdrawal of care orders for 48 hours

Referral to Intensive Care

Immediate (<30 min) referral to intensive care if airway, breathing and/or circulation are compromized

Referral to Neurosurgery

Immediate (<30 min) referral to neurosurgery if any of the following criteria are fulfilled:

  • Large and/or rapidly evolving supratentorial ICH (>20 ml volume)
  • Any intraventricular extension
  • Posterior fossa bleed, irrespective of volume
  • Suspicion of a vascular malformation, independent of volume or location
  • Reduction in reaction to sensory stimulation or drowsiness

Repeat brain imaging

Repeat 6-12-hour brain imaging with the physicians choice of modality, preferably computed tomography (CT), if clinical deterioration or the patient received OAC reversal treatment

Standard care

For patients in the usual-care group, decisions about the location of care delivery, investigations, monitoring, and all treatments are made by the treating clinical team. Data will be collected regarding the management of patients, including insertion of invasive monitoring devices, intravenous fluid resuscitation, BP lowering, vasoactive support, glycemic control, mechanical ventilation, neurosurgery, and other supportive therapy.

Primary outcome measure

  • Evaluation of functional outcome based on the Utility Weighted modified Rankin Scale score [ Time Frame: 180±30 days ]

Central Contacts and Locations

Central contacts

Teresa Ullberg, MD, PhD

0046175057i-catcher@med.lu.se

Trine Apostolaki-Hansson, MD PhD

trine.apostolaki-hansson@med.lu.se

Locations

The University of Oklahoma Health

Recruiting

Oklahoma City, Oklahoma, United States, 73126-0901

Contacts

Faddi G. Saleh Velez, MD

405-271-4113Faddi-SalehVelez@ou.edu

Health Sciences North/Health Sciences North Research Institute

Recruiting

Greater Sudbury, Ontario, Canada, P3E 5J1

Contacts

Ravinder Singh, MD

705-523-7300ravsingh@hsnsudbury.ca

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Aristeidis Katsanos, MD, PhD

905-521-2100Aristeidis.Katsanos@phri.ca

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

Contacts

Dar Dowlatshahi, MD PhD FRCPC

+1 613-761-4709ddowlat@toh.ca

More Information

Sponsor

Region Skane

Last update posted

May 22, 2026

Last verified

May, 2025

Keywords

  • intracerebral hemorrhage
  • oral anticoagulant
  • blood pressure lowering
  • early intensive blood pressure lowering
  • care bundle
  • implementation study
  • reversal treatment
  • outcome
  • UW-mRS
  • Modified Rankin Scale

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Region Skane on 2026-05-22.