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

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ClinicalTrials.gov Identifier: NCT03948256
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : May 2, 2022
Sponsor:
Information provided by (Responsible Party):
Tiit Mathiesen, Rigshospitalet, Denmark

Brief Summary:

To assess the benefits and harms of two commonly used regimens for external ventricular drainage cessation in in patients with hydrocephalus following aneurysmal subarachnoid haemorrhage a randomized controlled setting.

Design: Investigator-initiated, multi-centre, 1:1 randomized, parallel group, outcome assessment blinded clinical trial of gradual weaning vs. prompt closure of external ventricular drainage in patients with hydrocephalus following aneurysmal SAH


Condition or disease Intervention/treatment Phase
Aneurysmal Subarachnoid Hemorrhage Hydrocephalus Procedure: Control intervention Procedure: Experimental intervention Not Applicable

Detailed Description:

To assess the benefits and harms of two commonly used regimens for external ventricular drainage cessation in in patients with hydrocephalus following aneurysmal subarachnoid haemorrhage a randomized controlled setting.

Design: Investigator-initiated, international multi-centre, 1:1 randomized, parallel group, outcome assessment blinded clinical trial of gradual weaning vs. prompt closure of external ventricular drainage in patients with hydrocephalus following aneurysmal SAH

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 randomization
Masking: Single (Outcomes Assessor)
Masking Description: Due to the nature of the intervention with two arms with different time course it is not possible to mask patients nor investigators or care providers
Primary Purpose: Treatment
Official Title: Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage (DRAIN)
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : February 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control intervention
Prompt closure, based on best available scientific data
Procedure: Control intervention
Prompt closure of EVD with subsequent observation period
Other Name: Prompt closure

Experimental: Experimental intervention
Gradual weaning, based on best available scientific data
Procedure: Experimental intervention
Gradual weaning of EVD with 5 cmH2O increase in drainage resistance daily until complete closure with subsequent observation period
Other Name: Gradual weaning




Primary Outcome Measures :
  1. Any serious adverse event (SAE) including all-cause mortality [ Time Frame: 6 months after ictus ]
    Serious adverse events incl. mortality within 6 months after ictus


Secondary Outcome Measures :
  1. Serious adverse event (SAE) excl. mortality [ Time Frame: 6 months after ictus ]
    Serious adverse events excl. mortality within 6 months after ictus


Other Outcome Measures:
  1. Quality of Life measured by scale [ Time Frame: 6 months after ictus ]
    European Quality of Life (EQ-5D)

  2. Functional outcome [ Time Frame: 6 months after ictus ]
    modified Rankin Scale (mRS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stable or improving neurological status (GCS) during the last 24 hours
  • No clinical or radiological signs of cerebral vasospasms as delayed neurological deficits (DND) during the last 24 hours
  • Signed informed consent from patient or next-of-kin

Exclusion Criteria:

  • 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 based on clinical investigations
  • Lack of signed informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948256


Contacts
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Contact: Tenna Capion, MD (+45)22772588 tenna.baek.capion@regionh.dk

Locations
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Denmark
Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Tenna Capion, MD    (+45) 35450845    tenna.baek.capion@regionh.dk   
Contact: Tiit Mathiesen, DMSc    (+45) 35453188    tiit.illimar.mathiesen@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Tiit I Mathiesen, DMSc Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet
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Responsible Party: Tiit Mathiesen, Principal investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03948256    
Other Study ID Numbers: H-18054954
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data wille be available upon reasonable request and only after approval from local authorities and involving parties.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tiit Mathiesen, Rigshospitalet, Denmark:
External ventricular drain
Weaning
Closure
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Hydrocephalus
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases