Desmopressin for Reversal of Antiplatelet Drugs in Stroke Due to Haemorrhage

What Was Tested

In this phase 2 trial, researchers set out to test Desmopressin.

A quarter of these patients are taking blood-thinning drugs (antiplatelet drugs, such as aspirin) because they are at risk of a heart attack or ischaemic stroke.

Patients taking these drugs are more likely to die or be disabled if they have a haemorrhagic stroke.

It had two arms (groups): Intervention (experimental) and Control (placebo comparator).

Desmopressin injection.

Normal Saline.

The registry classes the interventions as drug.

More on the Plan

Intracerebral haemorrhage is a medical emergency, caused by a blood vessel bleeding directly into the brain.

Outcome is directly related to the amount of bleeding that occurs.

Four to five million people are taking antiplatelet drugs in the UK and use continues to rise in an ageing population.

Treatment for intracerebral haemorrhage has been identified as a priority area by Stroke Association and stroke survivors.

Who Took Part

54 actual participants took part.

It was open to people of any sex aged from 18 years up to 110 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adults (≥18 years). Confirmed intracerebral haemorrhage on imaging. Less than 24 hours from onset of symptoms \[or from when last seen free of stroke symptoms\]. 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 (or waiver of consent).

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: aneurysmal subarachnoid haemorrhage known at time of enrolment; haemorrhage suspected to be due to transformation of ischaemic stroke; haemorrhage known to be due to thrombolytic drug.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Desmopressin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Desmopressin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2019-04-01 with completion listed for 2022-06-30.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of eligible patients who received allocated treatment (time frame: 90 days). Rate of eligible patients randomised (time frame: 18 months). Proportion of eligible patients and randomised (time frame: 18 months).

It also tracked 11 secondary outcomes, for example Number of patients dead or suffered serious adverse events, Change in intracerebral haemorrhage volume at 24 hours, Disability - Barthel index, Quality of life - EuroQol, Cognition - telephone MMSE and Length of hospital stay.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Desmopressin in 54 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Desmopressin compound page, all human trials.