Care bundle tested for brain bleeds caused by spontaneous intracerebral hemorrhage

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who have a bleed inside the brain (intracerebral haemorrhage) that started on its own, seen on a CT scan, within 24 hours of the first symptoms.

Age

18 years or older

Sex

Women and men can join.

Disease stage

Spontaneous bleeding inside the brain, confirmed on a non-contrast CT scan, with symptoms starting 24 hours ago or less (or last seen well 24 hours ago or less).

Main reasons for not taking part

• Previous limits on the care a person wants
• Serious end-stage illness with life expectancy under 6 months, for example terminal cancer
• Bleed caused by a brain tumour or a blood clot in the brain's veins (cerebral venous thrombosis)
• Signs of brain herniation at first presentation (unresponsive, with both pupils fixed and maximally dilated)
• Pregnant women beyond 22 weeks can join only after thorough discussion with an obstetrician

The registry criteria, word for word

What the trial wants to find out

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.

The 2 groups in the trial

• Intervention groupExisting treatment, for comparison

  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

  Treatment: 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, Referral to Intensive Care, Referral to Neurosurgery, and Repeat brain imaging

• Usual carePlacebo, for comparison

  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.

  Treatment: Standard care