Details of the study
- To determine if a care bundle (including early blood pressure control, hyperglycaemia, pyrexia, and abnormal coagulation management) improves functional outcome at 6 months in patients with acute spontaneous intracerebral haemorrhage presenting within 6 hours of symptom onset.
Study design
- Class Of Evidence
- Stepped wedge cluster randomised controlled trial
- Randomisation
- Central randomisation using permuted blocks to three sequences, stratified by country and projected patient numbers
- Number Of Patients
- 7036 (3221 intervention, 3815 control)
- Length Of Follow Up
- 6 months
- Number Of Centres
- Not stated in the paper
- Stratification
- Country and projected patient numbers
- Outcome Measures
- Functional outcome at 6 months
Results
- Systolic blood pressure target <140 mm Hg reached in 96.7% of care bundle patients versus 94.4% of usual care patients.
- Blood glucose target reached in 13.4% of care bundle patients versus 6.5% of usual care patients.
- Temperature target (≤37.5°C) reached in 86.5% of care bundle patients versus 83.8% of usual care patients.
Conclusion
- The care bundle protocol improved functional outcome at 6 months.
Critique
- Conducted in diverse healthcare settings across 10 countries.
- Recruitment suspended in Chile, Pakistan, and Peru due to the COVID-19 pandemic.