Haemorrhagic stroke Circulatory System Intracerebral haemorrhage
Conditions
Interventions
Patients will be randomly allocated to receive either:
Intravenous desmopressin: 20 µg in 50 ml Sodium Chloride 0.9% infused over 20 min
Comparator: placebo (Sodium Chl
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 12/02/2020: 1. Aged >18 years 2. Confirmed intracerebral hemorrhage on imaging 3. Less than 24 hours from onset of symptoms (or from when last seen healthy) 4. Prescribed and thought to be taking a daily oral antiplatelet drug in the preceding seven days (cyclooxygenase inhibitors, phosphodiesterase inhibitors or P2Y12 inhibitors) 5. Signed consent (patient/personal/professional representative) Previous participant inclusion criteria: 1. Adults (>17 years) 2. Confirmed intracerebral haemorrhage on imaging 3. Less than 12 hours from onset of symptoms [or from when last seen healthy] 4. Prescribed and thought to be taking a daily oral antiplatelet drug in the preceding seven days (cyclooxygenase inhibitors, phosphodiesterase inhibitors or P2Y12 inhibitors) 5. Signed consent (patient/personal/professional representative)
Exclusion criteria
Exclusion criteria: 1. Aneurysmal subarachnoid haemorrhage known at time of enrolment 2. Haemorrhage known to be due to transformation of infarction 3. Haemorrhage known to be due to thrombolytic drug 4. Haemorrhage known to be due to venous thrombosis 5. Risk/s of fluid retention associated with desmopressin judged clinically significant by the attending physician (for example patients with pulmonary oedema and/or cardiac failure) 6. Significant hypotension (systolic blood pressure 4 13. Participation in another concurrent drug trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of randomising, administering the intervention, and completing follow-up for patients treated with desmopressin or placebo to inform a definitive trial; Timepoint(s): End of the study; assessed using: 1. Number of eligible patients who receive allocated treatment 2. Rate of eligible patients randomised 3. Proportion of eligible patients approached 4. Proportion of eligible patients randomised and reasons for non-randomisation 5. Adherence to intervention 6. Proportion of participants followed up to 90 days and reasons for loss to follow up 7. Proportion of randomised participants with full outcome data available, and reasons for non-availability | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hyponatraemia, measured using U&E blood test (Sodium Na level) at 24 hours 2. Early case fatality <28 days, measured using SAE recording/death/discharge CRF 3. Case fatality at day 90, measured using alive and well check GP 4. Serious adverse events (including thromboembolic events) up to day 90, measured using SAE reporting CRF 5. Change in intracerebral haemorrhage volume at 24 hours, measured using CT/MRI scan volume measurement 6. Discharge destination, measured using discharge CRF at discharge 7. Disability, measured using the Barthel index at day 90 8. Quality of life, measured using EuroQol at day 90 9. Cognition, measured using telephone MMSE at day 90 10. Length of hospital stay, measured using hospital admission record at discharge 11. Health economic assessment using EQ-5D at day 90 follow up 12. Assessment of baseline platelet dysfunction (P-selectin) and correlation with response to desmopressin, measured using P-selectin blood test at enrollment after consent pre-treatment 13. Change in factor VIII, VWF antigen and VWF activity at one hour after administration of desmopressin, measured using factor VIII, VWF antigen and VWF assays done on blood tests taken before and after treatment | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed