24 or 48 hours of drainage after operation for a blood collection on the brain's surface
| ISRCTN | ISRCTN17021467 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17021467 |
- Submission date
- 20/10/2020
- Registration date
- 30/10/2020
- Last edited
- 06/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
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
Contact information
Scientific
Krogstens Alle 24
Hvidovre
2650
Denmark
 ORCID ID |
0000-0002-9083-808X |
|---|---|
| Phone | +45 22334149 |
| thorbjoern.soeren.roenn.jensen.01@regionh.dk |
Study information
| Study design | Randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN17021467_PIS_Danish version.docx |
| Scientific title | Twenty-four versus 48 hours drainage after burr hole evacuation of chronic subdural hematoma: A national randomized controlled study |
| Study acronym | 24vs48CSDH |
| Study objectives | 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(s) | Approved 05/03/2018, Scientific Ethical Committee of Copenhagen (Regionhuset, Damhaven 12, 7100 Vejle, Denmark; +45 76638221; komite@rsyd.dk), ref: S-20180010 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Recurrent hematomas within 90 days measured using patient records |
| Secondary outcome measures | Death within 90 days measured using patient records |
| Overall study start date | 01/09/2017 |
| Completion date | 01/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 420 |
| Total final enrolment | 420 |
| Key inclusion criteria | Patients age 60 or above who presented with a symptomatic CSDH proven by computed tomography or magnetic resonance |
| Key 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 |
| Date of first enrolment | 01/09/2018 |
| Date of final enrolment | 01/07/2020 |
Locations
Countries of recruitment
- Denmark
Study participating centres
Copenhagen
2100
Denmark
Odense
5000
Denmark
Aarhus
8200
Denmark
Aalborg
9100
Denmark
Sponsor information
Hospital/treatment centre
Department of Neurosurgery
Opgang 6, 3. sal
Inge Lehmanns Vej 6
Copenhagen
2100
Denmark
| Phone | +45 35456031 |
|---|---|
| Morten.Ziebell@regionh.dk | |
| Website | https://www.rigshospitalet.dk/afdelinger-og-klinikker/neuro/hjerne-og-nervekirurgi/Sider/default.aspx |
"ROR" |
https://ror.org/03mchdq19 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Location
- Denmark
Results and Publications
| Intention to publish date | 01/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 06/11/2020 | No | Yes |
Additional files
- ISRCTN17021467_PIS_Danish version.docx
- uploaded 06/11/2020
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
