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NCT Number: NCT03948256

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

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.

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

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Key information

Conditions

Aneurysmal Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Hydrocephalus Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurosurgery, Odense University Hospital, Odense, Region Syd, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >= 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)

Exclusion criteria

  • 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

Treatment and study plan

Control intervention

Procedure

Prompt closure of EVD with subsequent observation period

Other names: Prompt closure

Experimental intervention

Procedure

Gradual weaning of EVD with 5 cmH2O increase in drainage resistance daily until complete closure with subsequent observation period

Other names: Gradual weaning

Primary outcomes

  1. VP-shunt implantation, all-cause mortality, or EVD-related infection.

    Time frame: 6 months after ictus

    The primary outcome is a composite outcome of VP-shunt implantation, all-cause mortality, and EVD-related infection.

Secondary outcomes

  1. Number of serious adverse events (SAE) not including death

    Time frame: 6 months after ictus

    Number of serious adverse events (SAE) not including death as defined according to International Conference of Harmonization of Good Clinical Practice (ICH-GCP) at 6 months (count outcome)

  2. Health-related quality of life (EQ-5D-5L)

    Time frame: 6 months after ictus

    Health-related quality of life (EQ-5D-5L) at 6 months with the primary assessment being self- assessment of own health (EQ VAS; 0 to 100 point scale, 100 being the best possible outcome)) (continuous outcome)

Other outcomes

  1. Functional outcome according to modified Rankin Scale

    Time frame: 6 months after ictus

    Functional outcome according to mRS at 6 months, (1-6 scale, 1 being the best possible outcome)) (ordered categorical outcome)

  2. The remaining dimensions of EQ-5D-5L

    Time frame: 6 months after ictus

    The remaining dimensions of EQ-5D-5L (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) at 6 months (1-5 levels, 1 being the best possible outcome) (count outcome)

  3. Fatigue Severity Scale (FSS)

    Time frame: 6 months after ictus

    Fatigue Severity Scale (FSS) at 6 months (1-7 scale, 1 being the best possible outcome) (ordered categorical outcome)

  4. Glasgow Outcome Scale Extended (GOSE)

    Time frame: 6 months after ictus

    Glasgow Outcome Scale Extended (GOSE) at 6 months (1-8 scale, 8 being the best possible outcome) (ordered categorical outcome)

  5. Reason for failure of EVD cessation

    Time frame: At time of failure (assessed up to 6 months)

    Reason for failure of EVD cessation (ICP elevation, drop in GCS by 2 points or more, and/or clinical deterioration)

  6. Glasgow Coma Score (GCS) on discharge from the Neuro Intensive Care Unit and Neurosurgical department (3-15 scale, 15 being the best possible outcome)

    Time frame: At time of discharge (assessed up to 6 months)

    Glasgow Coma Score (GCS) on discharge from the Neuro Intensive Care Unit and Neurosurgical department (3-15 scale, 15 being the best possible outcome)

  7. Length of stay in Neuro Intensive Care Unit and hospital

    Time frame: At time of discharge (assessed up to 6 months)

    Length of stay in Neuro Intensive Care Unit and hospital

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Acronym: DRAIN

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
May 13, 2019
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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