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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03948256
Other study ID # H-18054954
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 6, 2019
Est. completion date July 1, 2024

Study information

Verified date May 2023
Source Rigshospitalet, Denmark
Contact Tenna Capion, MD
Phone (+45)22772588
Email tenna.baek.capion@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 244
Est. completion date July 1, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Control intervention
Prompt closure of EVD with subsequent observation period
Experimental intervention
Gradual weaning of EVD with 5 cmH2O increase in drainage resistance daily until complete closure with subsequent observation period

Locations

Country Name City State
Denmark Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet Copenhagen
Denmark Department of Neurosurgery, Odense University Hospital Odense Region Syd
Norway Department of Neurosurgery, Oslo University Hospital Oslo
Norway Department of Neurosurgery, University Hospital of North Norway Tromsø

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Countries where clinical trial is conducted

Denmark,  Norway, 

Outcome

Type Measure Description Time frame Safety issue
Other Functional outcome according to modified Rankin Scale Functional outcome according to mRS at 6 months, (1-6 scale, 1 being the best possible outcome)) (ordered categorical outcome) 6 months after ictus
Other The remaining dimensions of EQ-5D-5L 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) 6 months after ictus
Other Fatigue Severity Scale (FSS) Fatigue Severity Scale (FSS) at 6 months (1-7 scale, 1 being the best possible outcome) (ordered categorical outcome) 6 months after ictus
Other Glasgow Outcome Scale Extended (GOSE) Glasgow Outcome Scale Extended (GOSE) at 6 months (1-8 scale, 8 being the best possible outcome) (ordered categorical outcome) 6 months after ictus
Other Reason for failure of EVD cessation Reason for failure of EVD cessation (ICP elevation, drop in GCS by 2 points or more, and/or clinical deterioration) At time of failure (assessed up to 6 months)
Other Glasgow Coma Score (GCS) on discharge from the Neuro Intensive Care Unit and Neurosurgical department (3-15 scale, 15 being the best possible outcome) Glasgow Coma Score (GCS) on discharge from the Neuro Intensive Care Unit and Neurosurgical department (3-15 scale, 15 being the best possible outcome) At time of discharge (assessed up to 6 months)
Other Length of stay in Neuro Intensive Care Unit and hospital Length of stay in Neuro Intensive Care Unit and hospital At time of discharge (assessed up to 6 months)
Primary VP-shunt implantation, all-cause mortality, or EVD-related infection. The primary outcome is a composite outcome of VP-shunt implantation, all-cause mortality, and EVD-related infection. 6 months after ictus
Secondary Number of serious adverse events (SAE) not including death 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) 6 months after ictus
Secondary Health-related quality of life (EQ-5D-5L) 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) 6 months after ictus
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