Intracerebral Haemorrhage
Conditions
Keywords
Intracerebral Haemorrhage, blood pressure treatment, acute blood pressure treatment, nicardipine, glyceryl trinitrate
Brief summary
Quality improvement study with a quasi-randomized design. The study monitors the effect of a gradually implemented treatment algorithm prioritizing intravenous antihypertensives (e.g., nicardipine) over long-acting nitrate patches. It aims to increase the proportion of patients reaching target systolic BP \<140 mmHg within 1 hour of hospital admission while monitoring safety, clinical outcomes, and healthcare resource utilization.
Detailed description
Spontaneous intracerebral hemorrhage (ICH) is one of the most time-critical neurological emergencies. Rapid lowering of systolic blood pressure to below 140 mmHg (but not below 110 mmHg) has been associated with reduced risk of hematoma expansion and improved long-term functional outcomes. International guidelines recommend that the target blood pressure be achieved within 1 hour of hospital admission. Traditionally, the specific class of antihypertensive agent used for acute blood pressure management in ICH was considered less important than achieving the target level. However, emerging evidence from two randomized clinical trials has raised concerns regarding the safety of transdermal long-acting nitrate patches (such as glyceryl trinitrate) in the hyperacute phase of stroke. These studies reported signals suggesting potential harm when nitrate patches were used in the early hours after symptom onset. Further, the time from derug administration to blood-pressure control is longer than intravenous administration. In contrast, intravenous calcium channel blockers such as nicardipine have demonstrated both efficacy and safety in achieving rapid blood pressure control in acute ICH. These agents are widely used in clinical practice and are recommended in national and international guidelines. In our institution, the standard protocol for acute blood pressure management in ICH has historically included transdermal glyceryl trinitrate patches. In light of emerging safety concerns and new recommendations, we aim to gradually implement a revised protocol centered on intravenous nicardipine. The implementation will be conducted in a cluster randomized stepwise fashion and monitored closely for its effects on blood-pressure control, safety, workflow, and resource utilization.
Interventions
COMBINATION_PRODUCTNicardipine
Nicardipine infusion based acute blood pressure lowering treatment
COMBINATION_PRODUCTGlyceryl trinitrate
Glyceryltrinitrate based acute blood pressure lowering treatment
Sponsors
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors for 90 days modified Rankin Scale
Intervention model description
Prospective, quasi-randomized, implementation and quality improvement trial with stepwise rollout
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Acute spontaneous Intracerberal Hemorrhage confirmed by imaging * Symptom onset to stroke center admission \<24 hours * Elevated systolic blood pressure (\>140 mmHg) at admission
Exclusion criteria
* Secondary causes of ICH (e.g., trauma, vascular malformation) * Presumed fatal bleeding at admission * Short remaining life expectancy (\<12 month)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target blood pressure < 140 mmHg 1 hour after admission. | 1 hour after stroke center admission | Proportion of patients reaching systolic BP \<140 mmHg within 1 hour of stroke center admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome at 3 months | 90 days (+/- 14 days) | Proportion of patients with acceptable functional outcome at 3 months Defined as modified Rankin Scale (mRS) ≤ 3 |
| Bed day use | 0 to 180 days | Use of acute stroke unit bed-days |
| Total bed day use | 0 to 180 days | Use of total unit bed-days (Stroke ward and in-hospital rehabilitation) |
| Serious adverse events | 90 days | Proportion of patients with at least one serious adverse events (SAEs) |
| Hypotension | 0 to 90 days | Proportion of patients experiencing hypotension (systolic blood rpessure \<90mmHg or diastolic below 60 mmHg) during the stroke center admission |
| Reduced level of consciousness | 0 to 90 days | Reduced level of consciousness measured as a drop of at least 2 points on the Glascow Coma Scale (range 3-15) |
| Intensive care unit | 0 to 90 days | Proportion of patients admitted to the intensive carte unit |
| Neurosurgery | 0 to 90 days | Incidence of surgical intervention (hematoma evacuation or external ventricular drainage) during hospital stay |
| Mortality | 90 days (+/- 14 days) | All cause mortality at 90 days |
| Acute kidney injury | 0 to 90 days | Proportion of patients experiencing acute kidney injury during the stroke center admission. (Increase in plasma creatinine of more than 26.5 µmol/L within the past 48 hours, or Increase of 50% or more within 7 days from baseline, defined as the patient's habitual creatinine level, or Urine output of less than 0.5 mL/kg/hour over the past 6 hours despite appropriate therapy) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time consumption associated with blood pressure management | From 0 to 72 hours | Nursing time per patient related to acute blood pressure management ( Estimated via time registration in sample patients, 3-5 in each group) |
Contacts
Primary ContactRolf Blauenfeldt, MD, PhD
Backup ContactClaus Z Simonsen, MD, PhD
Outcome results
None listed