Desmopressin for treatment of stroke patients on antiplatelet therapy

Phase 2

Completed

• Conditions: Haemorrhagic stroke; Circulatory System; Intracerebral haemorrhage

• Registration Number: ISRCTN67038373
• Lead Sponsor: niversity of Nottingham

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33172941/ Peer reviewed protocol article (added 11/08/2022) 2023 Results article in https://doi.org/10.1016/S1474-4422(23)00157-6 (added 22/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-22
• Study Completion: 2022-06-30
• Last Update Posted: 4 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 54

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

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 < 90mmHg)
7. Known drug-eluting coronary artery stent in previous three months
8. Allergy to desmopressin
9. Pregnant or breastfeeding
10. Life expectancy less than four hours, or planned for palliative care only
11. Glasgow coma scale less than 5
12. mRS > 4
13. Participation in another concurrent drug trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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:<br> 1. Number of eligible patients who receive allocated treatment<br> 2. Rate of eligible patients randomised<br> 3. Proportion of eligible patients approached<br> 4. Proportion of eligible patients randomised and reasons for non-randomisation<br> 5. Adherence to intervention<br> 6. Proportion of participants followed up to 90 days and reasons for loss to follow up<br> 7. Proportion of randomised participants with full outcome data available, and reasons for non-availability<br>