The Intracerebral Hemorrhage Acutely Decreasing Arterial Pressure Trial II
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
The vast majority of intracerebral hemorrhage (ICH) patients present with elevated blood
pressure(BP). Management of BP is controversial with two competing rationales. There is some
evidence that hyperacute treatment may improve outcomes by reducing the rate of hematoma
expansion. Physicians have been reluctant to reduce BP early after ICH onset, fearing reduced
cerebral blood flow (CBF) will increase ischemia and increase the risk of further damage.
Other confounding mediators to further ischemic injury following ICH include increased
platelet activity, withdrawal of antithrombotic therapy, endothelial dysfunction,
inflammation and hypercoagulability.
This study is phase II of the ICH-ADAPT study. The investigators hypothesize that aggressive
antihypertensive therapy will alter the natural history of heamatoma growth, improving
outcomes after Intracranial Hemorrhage (ICH). The previous phase I ICH-ADAPT study has
established the safety of early BP treatment.
The investigators have designed a phase II study in which ICH patients are randomized to
aggressive versus conservative BP treatment using a deferred consent procedure. An adaptive
randomization will be used to treat BP to < 140 mmHg SBP or < 180 mmHg SBP. Treatment must be
implemented as soon as possible after radiological confirmation of diagnosis.
Antihypertensive therapy must begin within 6 hours of symptom onset. The patient will be
re-imaged 24 hours later. The patient will have continuous non-invasive BP and heart rate(HR)
monitoring for a minimum of 24 hours. Antihypertensive drug use and dosage will be recorded
with BP and HR. Patients will be monitored regularly until study completion. MRI's will be
done at 48 hours, day 7 and day 30. This imaging will help to detect ischemic changes that
may occur. Blood will be collected at the same time as the MRI. Blood analysis will be done
to possibly identify biomarkers that may be putative mediators of ischemic injury in ICH
patients.