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出境医 / 临床实验 / Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage (DRAIN)

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

Study Description
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
Layout table for study information
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
Arms and Interventions
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
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

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
Tracking Information
First Submitted Date  ICMJE April 4, 2019
First Posted Date  ICMJE May 13, 2019
Last Update Posted Date June 10, 2019
Actual Study Start Date  ICMJE June 6, 2019
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2019) 		Any serious adverse events (SAE) including all-cause mortality [ Time Frame: 6 months after admission ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2019) 		SAE not including mortality [ Time Frame: 6 months after admission ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 10, 2019) 		Ventriculo-peritoneal shunt rate [ Time Frame: 6 months after admission ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage
Official Title  ICMJE Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage (DRAIN)
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Aneurysmal Subarachnoid Hemorrhage
  • Hydrocephalus
Intervention  ICMJE
  • Procedure: Control intervention
    Prompt closure of EVD with subsequent observation period
    Other Name: Prompt closure
  • 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
Study Arms  ICMJE
  • Active Comparator: Control intervention
    Prompt closure, based on best available scientific data
    Intervention: Procedure: Control intervention
  • Experimental: Experimental intervention
    Gradual weaning, based on best available scientific data
    Intervention: Procedure: Experimental intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2019) 		244
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tenna Capion, MD (+45)22772588 tenna.baek.capion@regionh.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03948256
Other Study ID Numbers  ICMJE H-18054954
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Tiit Mathiesen, Rigshospitalet, Denmark
Study Sponsor  ICMJE Rigshospitalet, Denmark
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rigshospitalet, Denmark
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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