International Care Bundle Evaluation in Cerebral Hemorrhage Research

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
Region Skane
Study ID
NCT06429332
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cerebrovascular Disease
  • Intracerebral Haemorrhage
  • Intracerebral Hemorrhage
  • Intraventricular Hemorrhage
  • Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Reversal of Oral anticoagulation within 30 minutes — OTHER
    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 — OTHER
    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 — OTHER
    To achieve a body temperature target \<37.5 °C within the first 24h following ICH diagnosis on NCCT
  • Hyperglycemia treatment — OTHER
    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 — OTHER
    Refrain from the use of DNR or withdrawal of care orders for 48 hours
  • Referral to Intensive Care — OTHER
    Immediate (\<30 min) referral to intensive care if airway, breathing and/or circulation are compromized
  • Referral to Neurosurgery — OTHER
    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 — DIAGNOSTIC_TEST
    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 — OTHER
    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.

Study Details

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 Dates

Start date
Jan 7, 2025
Status verified
May 2025
Primary completion
Mar 1, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
3,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Oklahoma HealthOklahoma CityOklahoma73126-0901
Faddi G. Saleh Velez, MD
[email protected]
405-271-4113

Find similar trials in Oklahoma City, OK

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
The University of Oklahoma Health· Oklahoma City, OK

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