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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 : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Tiit Mathiesen, Rigshospitalet, Denmark

Study Description
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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, single-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

Study Design
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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 : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


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

Secondary Outcome Measures :
  1. SAE not including mortality [ Time Frame: 6 months after admission ]

Other Outcome Measures:
  1. Ventriculo-peritoneal shunt rate [ Time Frame: 6 months after admission ]

Eligibility Criteria
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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
Contacts and Locations
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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 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
More Information
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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: June 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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