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

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Brief Title

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

Official Title

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, 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
    

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
    


Study Type

Interventional


Primary Outcome

Any serious adverse event (SAE) including all-cause mortality

Secondary Outcome

 Serious adverse event (SAE) excl. mortality

Condition

Aneurysmal Subarachnoid Hemorrhage

Intervention

Control intervention

Study Arms / Comparison Groups

 Control intervention
Description:  Prompt closure, based on best available scientific data

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

244

Start Date

June 6, 2019

Completion Date

February 1, 2024

Primary Completion Date

August 1, 2023

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Tiit I Mathiesen, DMSc, (+45)22772588, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT03948256

Organization ID

H-18054954


Responsible Party

Principal Investigator

Study Sponsor

Rigshospitalet, Denmark


Study Sponsor

Tiit I Mathiesen, DMSc, Principal Investigator, Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet


Verification Date

April 2022