A trial to assess whether desmopressin could reduce risk of death or disability for patients with intracerebral haemorrhage (bleeding into the brain) taking antiplatelet (blood thinning ) drugs. study will be modified Rankin scale at day 90 (shift analysis).

Phase 1

• Conditions: Intracerebral haemorrhage; MedDRA version: 21.1 Level: PT Classification code 10019016 Term: Haemorrhagic stroke System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-001904-12-GB
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-12
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: A
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Adults (>16 years)
Confirmed intracerebral haemorrhage on imaging
Less than 12 hours from onset of symptoms [or from when last seen healthy]
Prescribed and thought to be taking a daily oral antiplatelet drug in the preceding seven days (cyclooxygenase inhibitors, phosphodiesterase inhibitors or P2Y12 inhibitors)
Signed consent (patient/personal/professional representative)

Are the trial subjects under 18? yes
Number of subjects for this age range: 2
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

Aneurysmal subarachnoid haemorrhage known at time of enrolment
Haemorrhage known to be due to transformation of infarction
Haemorrhage known to be due to thrombolytic drug
Haemorrhage known to be due to venous thrombosis
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)
Significant hypotension (systolic blood pressure <90mmHg)
Known drug-eluting coronary artery stent in previous three months
Allergy to desmopressin
Pregnant or breast-feeding
Life expectancy less than four hours, or planned for palliative care only
Glasgow coma scale less than 5
mRS >4
Participation in another concurrent drug trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: At end of trial ;<br> Main Objective: To assess the feasibility of randomising, administering the intervention, and completing follow-up for patients treated with desmopressin or placebo to inform a definitive trial.<br> ;<br> Secondary Objective: To assess the effect of desmopressin on secondary outcomes:<br> clinical outcomes, safety outcomes, laboratory outcomes, costs and radiological efficacy.<br><br> ;Primary end point(s): To assess the feasibility of randomising, administering the intervention, and completing follow-up for patients treated with desmopressin or placebo to inform a definitive trial.