Condition category
Injury, Occupational Diseases, Poisoning
Date applied
20/10/2020
Date assigned
30/10/2020
Last edited
06/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A subdural haematoma is a serious condition where blood collects between the skull and the surface of the brain. It's usually caused by a head injury. A chronic subdural hematoma (SDH) is an old clot of blood on the surface of the brain beneath its outer covering. These liquefied clots most often occur in patients age 60 and older who have brain atrophy, a shrinking or wasting away of brain tissue due to age or disease.
This is a national study involving all neurosurgical departments in Denmark. We investigate 24 versus 48 hours of drainage following an operation for chronic subdural hematoma (CSDH).

Who can participate?
Patients age 60 or above who presented with a symptomatic CSDH

What does the study involve?
Patients will be randomly allocated to receive either 24 or 48 hours of drainage following the operation to remove the CSDH. Three months after the operation, patients are followed-up.

What are the possible benefits and risks of participating?
No immediate benefits, but findings will benefit future patients.
As the optimal drainage period is not known, we see no risk of participating.

Where is the study run from?
The study is run from all neurosurgical departments in Denmark.

When is the study starting and how long is it expected to run for?
September 2017 to May 2022

Who is funding the study?
Neurosurgical Department of Rigshospitalet, Copenhagen (Denmark)

Who is the main contact?
Thorbjørn Søren Rønn Jensen, tjens07@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Thorbjørn Søren Rønn Jensen

ORCID ID

http://orcid.org/0000-0002-9083-808X

Contact details

Krogstens Alle 24
Hvidovre
2650
Denmark
+45 22334149
thorbjoern.soeren.roenn.jensen.01@regionh.dk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Twenty-four versus 48 hours drainage after burr hole evacuation of chronic subdural hematoma: A national randomized controlled study

Acronym

24vs48CSDH

Study hypothesis

24 versus 48 hours of closed passive subdural drainage after single burr hole evacuation of chronic subdural hematoma are equal regarding recurrent hematomas and death.

Ethics approval

Approved 05/03/2018, Scientific Ethical Committee of Copenhagen (Regionhuset, Damhaven 12, 7100 Vejle, Denmark; +45 76638221; komite@rsyd.dk), ref: S-20180010

Study design

Randomized controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files (in Danish)

Condition

Preventing prolonged immobilisation due to presence of a subdural drain after evacuation of chronic subdural hematoma

Intervention

Participants were randomized to either 24 or 48 hours of closed, subdural, passive drainage following a single burr hole evacuation of a chronic subdural hematoma (CSDH).

After the operation for CSDH, the patient was registered in the Research Electronic Data Capture (Redcap) and assessed by either a member of DACSUHS or the attending neurosurgeon for inclusion within the first 24 hours. Included and consented patients were randomized using a web-based randomization software within Redcap. A closed envelope stating the time for drain removal was kept at the patient’s bed and opened 24 hours postoperative by the nursing staff. The drain was either removed or kept for an additional 24 hours according to randomization. As such, the randomization was blinded to the patient, the nursing staff, and physicians on the ward and both groups of patients received identical care for 24 hours.

Patients were discharged home or to a local hospital when they no longer needed specialized neurosurgical care, and when the hospital was ready to receive them. Routine postoperative CT was not carried out.
Three months after the operation, patients were followed-up for recurrent symptomatic CSDH, death and complications, including thromboembolic events following the surgery.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Recurrent hematomas within 90 days measured using patient records

Secondary outcome measures

Death within 90 days measured using patient records

Overall trial start date

01/09/2017

Overall trial end date

01/05/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients age 60 or above who presented with a symptomatic CSDH proven by computed tomography or magnetic resonance

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

420

Total final enrolment

420

Participant exclusion criteria

1. Previous intracranial surgery and known head injury within the last 14 days prior to surgery
2. Patients treated with craniotomy, multiple burr holes, subgaleal drain placement and if the drain was removed prior to study inclusion by either the patient or hospital staff
3. Patients unable to give formal consent

Recruitment start date

01/09/2018

Recruitment end date

01/07/2020

Locations

Countries of recruitment

Denmark

Trial participating centre

Rigshospitalet
Blegdamsvej 9
Copenhagen
2100
Denmark

Trial participating centre

Odense University Hospital
J. B. Winsløws Vej 4
Odense
5000
Denmark

Trial participating centre

Aarhus University Hospital
Palle Juul-Jensens Blvd. 161
Aarhus
8200
Denmark

Trial participating centre

Aalborg University Hospital
Hobrovej 18-22
Aalborg
9100
Denmark

Sponsor information

Organisation

Rigshospitalet

Sponsor details

Department of Neurosurgery
Opgang 6
3. sal
Inge Lehmanns Vej 6
Copenhagen
2100
Denmark
+45 35456031
Morten.Ziebell@regionh.dk

Sponsor type

Hospital/treatment centre

Website

https://www.rigshospitalet.dk/afdelinger-og-klinikker/neuro/hjerne-og-nervekirurgi/Sider/default.aspx

Funders

Funder type

Hospital/treatment centre

Funder name

Rigshospitalet

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

Denmark

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/12/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/11/2020: The participant information sheet was uploaded as an additional file. 22/10/2020: Trial’s existence confirmed by The Scientific Ethics Committees for the Region of Southern Denmark