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Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage

Key facts

Who runs it
Copenhagen University Hospital, Rigshospitalet
Where
Denmark and Norway4 sites in 2 countriesChoose a country to see its sites
Trial code
Status
Completed
People taking part
245 people enrolled
Started
6 Jun 2019
Ended
18 Jun 2024
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Control intervention
  • Experimental intervention
Record updated
25 June 2024

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • >= 18 years of age
  • Diagnosis of aneurysmal subarachnoid haemorrhage (aSAH)
  • External ventricular drain (EVD) for >= 6 days
  • Drain output of =< 220 mL on day of randomisation
  • Drain resistance of 10 or 15 cm H2O
  • Stable or improving Glasgow Coma Scale (GCS) >= 9 during the last 24 hours
  • Signed informed consent (from patient or next-of-kin)

Who cannot take part

  • None-tolerability of an increase of resistance to 10 cm H2O due to clinical deterioration or an increase in ICP
  • Severe pre-existing (physical or mental) disability or severe co-morbidity that would lead to poor outcome even if the patient made a full recovery from the aSAH
  • Life expectancy shorter than 48 hours after admission

This trial has no sites in United States.

It has sites in 2 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

The DRAIN trial is an international multi-centre, 1:1 randomised, parallel-group, superiority clinical trial investigating gradual weaning vs. prompt closure of external ventricular drainage in patients with hydrocephalus following aSAH.

Read full original descriptionShow less

The primary objective is to investigate the beneficial and harmful effects of gradual weaning versus prompt closure of EVD treatment in patients with aSAH.

The 2 groups in the trial

  • Control interventionExisting treatment, for comparison

    Prompt closure, based on best available scientific data

  • Experimental interventionTreatment being tested

    Gradual weaning, based on best available scientific data

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage (DRAIN)
Record updated
25 June 2024