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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06429332




Registration number
NCT06429332
Ethics application status
Date submitted
14/05/2024
Date registered
24/05/2024

Titles & IDs
Public title
International Care Bundle Evaluation in Cerebral Hemorrhage Research
Scientific title
International Care Bundle Evaluation in Cerebral Hemorrhage Research - a Batched Parallel Cluster-randomized Trial With a Baseline Period
Secondary ID [1] 0 0
2024-02523-01
Universal Trial Number (UTN)
Trial acronym
I-CATCHER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intracerebral Hemorrhage 0 0
Intracerebral Haemorrhage 0 0
Intraventricular Hemorrhage 0 0
Stroke 0 0
Cerebrovascular Disease 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Reversal of Oral anticoagulation within 30 minutes
Other interventions - Early intensive blood pressure lowering
Other interventions - Treatment of pyrexia
Other interventions - Hyperglycemia treatment
Other interventions - Do-not-resuscitate (DNR) or withdrawal of care
Other interventions - Referral to Intensive Care
Other interventions - Referral to Neurosurgery
Diagnosis / Prognosis - Repeat brain imaging
Other interventions - Standard care

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.


Other 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 hospital arrival 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.

Other interventions: Early intensive blood pressure lowering
A systolic blood pressure (BP) target of 130-140 mmHg within 30 minutes of commencing treatment 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.

Other interventions: Treatment of pyrexia
To achieve a body temperature target \<37.5 °C

Other interventions: Hyperglycemia treatment
To maintain a blood glucose level 7-10 mmol/L

Other interventions: Do-not-resuscitate (DNR) or withdrawal of care
Refrain from the use of DNR or withdrawal of care orders for 48 hours

Other interventions: Referral to Intensive Care
Immediate (\<30 min) referral to intensive care if airway, breathing and/or circulation are compromized

Other interventions: 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

Diagnosis / Prognosis: 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

Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluation of functional outcome based on the Utility Weighted modified Rankin Scale score
Timepoint [1] 0 0
180±30 days
Secondary outcome [1] 0 0
Ordinal shift analysis of mRS
Timepoint [1] 0 0
180 days±30 days
Secondary outcome [2] 0 0
Assessment of health-related quality of life (HRQoL)
Timepoint [2] 0 0
180 days±30 days
Secondary outcome [3] 0 0
Poor outcome defined as mRS 3-6
Timepoint [3] 0 0
180 days±30 days
Secondary outcome [4] 0 0
Separate outcomes for death and disability
Timepoint [4] 0 0
180 days±30 days

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
3500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The George Institute for Global Health - Sydney
Recruitment postcode(s) [1] 0 0
NSW 2000 - Sydney
Recruitment outside Australia
Country [1] 0 0
Sweden
State/province [1] 0 0
Malmö

Funding & Sponsors
Primary sponsor type
Other
Name
Region Skane
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The George Institute for Global Health, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Teresa Ullberg, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
0046175057
Fax 0 0
Email 0 0
i-catcher@med.lu.se
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06429332