Chronic Subdural HematomaDECIDENCT03053895
Bedside Versus Operating Room Burr-Hole Drainage of Chronic Subdural Hematoma (DECIDE)
A study testing CSDH - Bedside twist drill technique and CSDH - Operating Room Burr-hole technique in people with Chronic Subdural Hematoma, run by Hamilton Health Sciences Corporation.
Trial summary
DECIDE (Bedside versus Operating Room Burr-Hole DrainagE of ChronIc SubDural HEmatoma) CSDH is an abnormal collection of blood between the layers of the brain causing brain tissue compression leading to neurological complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- CSDH - Bedside twist drill technique and CSDH - Operating Room Burr-hole technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 486 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2017to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged >/= 18 years
- Presenting with symptomatic Chronic Subdural Hematoma confirmed on diagnostic imaging
- Able to provide informed consent or have a legal representatives available if unable to do so
Who cannot join
- Patients with acute or subacute subdural hematoma
- Patients with incidental or asymptomatic findings on CT; skull base, posterior fossa, or in the inter-hemispheric fissure Chronic Subdural Hematoma
- Patients with recurrent hematoma within 6 months of initial drainage
- Patients with Chronic Subdural Hematoma from previous intracranial surgery for different pathology Patients with subdural hygroma and non-hairline skull fracture over the Chronic Subdural Hematoma
- Patients with significant cognitive impairment or severe co-morbidity preventing improvement or follow-up
- Patients with hemorrhagic tendency that cannot be normalized
- Patients on anticoagulants, antithrombotics, or antiplatelets unless reversed or cleared - Patients who are unlikely to be available for a 6-month follow-up period
Trial locations and contacts
No sites are listed yet.
About this study
DECIDE (Bedside versus Operating Room Burr-Hole DrainagE of ChronIc SubDural HEmatoma)
CSDH is an abnormal collection of blood between the layers of the brain causing brain tissue compression leading to neurological complications. One of the most common risk factors contributing to CSDH is head trauma, which is usually in the form of a minor head injury. Older individuals are at increased risk of CSDH due to brain atrophy that occurs with advancing age as well as their tendency to fall and sustain minor head traumas. Chronic alcoholics are also at increased risk as alcoholism also leads to brain atrophy, increased risk of falls, and liver failure which results in increased bleeding risk. Also many drugs used today like anticoagulants, antithrombotics, and antiplatelets for certain health conditions are other common risk factors for CSDH.
Read more
The overall goal of this multi-centered trial in the USA and Canada is to assess the surgical management of chronic subdural hematoma (CSDH) and to demonstrate the effectiveness of bedside drainage and its safety as it bypasses the perioperative risk associated with anesthetic especially among the elderly.
Adult patients with a clear indication for CSDH drainage will be randomly assigned to one of two procedures. One group will receive the twist drill procedure which can be performed at the bedside. The second group will undergo the burr-hole drainage procedure in the operating room usually under general anesthetic. Typically, the twist drill procedure can occur sooner as the operating room and Anesthetist are not required. Reoccurrence of the CSDH will be assessed over a period of 6 months following drainage. Timing of procedure, risk of infection, adverse side effects and neurological functioning will also be measured.
Over a 3 year study period, 486 eligible patients (243 patients per arm) will be enrolled. Patients > 18 years with confirmed diagnosis of symptomatic CSDH will be provided one of the two procedures and will be followed for study outcomes at 1, 3 and 6 months following the procedure.
Primary analysis will be to compare the surgical procedures, assessing the recurrence rate of CSDH within 6 months of initial CSDH drainage.
The ultimate goal of this study is to standardize bedside drainage as the treatment of choice for CSDH management.
This trial is important in the ongoing search for more efficient and safe intervention strategies.
Read the detailed description
DECIDE (Bedside versus Operating Room Burr-Hole DrainagE of ChronIc SubDural HEmatoma)
Background and Significance: Chronic subdural hematoma (CSDH) is an abnormal collection of liquefied blood products between the dura and arachnoid membranes of the brain that may cause brain tissue compression and subsequent neurological sequelae. One of the most common risk factors contributing to CSDH is head trauma, which is usually in the form of a minor head injury. Older individuals are at increased risk of CSDH due to brain atrophy that occurs with advancing age as well as their tendency to fall and sustain minor head traumas. Chronic alcoholics are also at increased risk as alcoholism leads to globalized brain atrophy, increased risk of falls, and hepatogenic coagulopathy. Coagulopathies including the use of anticoagulants, antithrombotics, and antiplatelets for certain health conditions are other common risk factors for CSDH.
Study Aims: The primary aim of our study is to conduct a high-quality randomized trial to compare the safety and effectiveness of the bedside and operating room burr-hole drainage of CSDH. The main objective of this study is to demonstrate the effectiveness of bedside drainage and its safety as it bypasses the perioperative risk associated with anesthetic especially among the elderly.
The ultimate goal of this study is to standardize bedside drainage as the treatment of choice for CSDH management.
Primary Objective: To assess the efficacy of bedside drainage compared to operating room burr-hole evacuation for CSDH management by examining the hypothesis that bedside is associated with lower recurrence rate.
Secondary Objectives: To examine if the bedside drainage and the operating room burr-hole drainage are efficacious in terms of functional outcomes. To evaluate the hypothesis that bedside drainage is safer compared to the operating room burr-hole drainage by measuring mortality and morbidity.
Overall study design: Multi-centered pragmatic randomized controlled trial across North America (USA and Canada) comparing bedside drainage with operating room burr-hole drainage of CSDH.
Duration: Over a 3 year study period, each patient will be followed for 6 months to measure the study outcomes.
Study population: The study population will include 486 eligible patients >18 years of age with confirmed diagnosis of symptomatic CSDH (243 patients per arm).
Inclusion Criteria: Patients aged > 18 years presenting with symptomatic CSDH confirmed on diagnostic imaging, who are able to provide informed consent or have a legal representatives available if unable to do so.
Main intervention and comparator(s): Patients will be randomly assigned between the two arms of the study, bedside and operating room burr-hole drainage. For patients randomized to bedside drainage of CSDH, the twist-drill procedure will be conducted at the patient's bedside using local anesthetic. For patients randomized to burr-hole drainage, the procedure will be performed in the operating room under local or general anesthesia based on the surgeon's and anesthesiologist's judgement of the clinical stability of the patient. Randomization via www.randomize.net website will be stratified by center and by patient age in variable unspecified block sizes.
Follow-Up Post-Randomization: Patients randomized will be followed for study outcomes on days 1, 2, discharge, and months 1, 3 and 6.
Primary Outcome: The efficacy of comparative surgical procedures will be measured by the recurrence rate of CSDH within 6 months of initial CSDH drainage.
Secondary Functional Outcomes: Postoperative neurological and functional status of the patients will be measured using the Markwalder Grading System (MGS), Glasgow Outcome Score (GOS), and modified Rankin Scale (MRS).
Secondary Safety Outcomes: The safety of both procedures will be measured in terms of mortality and morbidity including surgical site infections, misplacement of postoperative subdural drain, tension pneumocephalus, new intracranial hemorrhage, and other medical complications.
Sample Size: Sample size estimation is based on a Chi-squared two-sided test of the null hypothesis that bedside drainage is not different from burr-hole drainage in reducing the proportion of patients who experience a hematoma recurrence within 6 months of the drainage procedure. Including for possible attrition rate of 10% a total of 486 patients (243 per arm) will be required to detect a difference in recurrence rates of 7% or a risk ratio of 0.36 (11% in the burr-hole group and 4% in the bedside drainage group), with a power of 80% and a level of significance set at alpha=0.05.
Primary Analysis: Primary analysis will be by intention-to-treat and data analyst will be blinded to participant allocation.
Interim Analyses: Interim analyses will be conducted upon recruitment of 25% of the expected sample size (122 patients) to assess recruitment rates, recurrence rates and safety outcomes.
This trial is important in the ongoing search for more efficient and safe intervention strategies.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- CSDH - Bedside twist drill technique, CSDH - Operating Room Burr-hole technique
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSDH - Bedside twist drill techniqueProcedure or surgery
For patients randomized to bedside drainage of CSDH, the twist-drill procedure will be conducted at the patient's bedside using local anesthetic
CSDH - Operating Room Burr-hole techniqueProcedure or surgery
For patients randomized to burr-hole drainage, the procedure will be performed in the operating room under local or general anesthesia based on the surgeon's and anesthesiologist's judgement of the clinical stability of the patient.
| Study group | Role | What they receive |
|---|---|---|
| CSDH Bedside twist drill technique | Experimental | For patients randomized to bedside drainage of Chronic Subdural Hematoma, the twist-drill procedure will be conducted at the patient's bedside using local anesthetic. Receives: Procedure: CSDH - Bedside twist drill technique |
| CSDH Operating Room Burr-hole technique | Active comparator | For patients randomized to burr-hole drainage, the procedure will be performed in the operating room under local or general anesthesia based on the surgeon's and anesthesiologist's judgement of the clinical stability of the patient. Receives: Procedure: CSDH - Operating Room Burr-hole technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of Chronic Subdural Hematoma
Measured: 6 months
Secondary outcomes (9)
Postoperative neurological and functional status - MGS
Postoperative neurological and functional status using Markwalder Grading System
Measured: 6 Months
Postoperative neurological and functional status - GOS
Postoperative neurological and functional status using Glasgow Outcome Score
Measured: 6 Months
Postoperative neurological and functional status - MRS
Postoperative neurological and functional status using modified Rankin Scale
Measured: 6 Months
surgical site infection rate
The safety of both procedures will be measured in terms of surgical site infections
Measured: 6 Months
safety - misplacement of postoperative subdural drain
The safety of both procedures will be measured in terms of misplacement of postoperative subdural drain
Measured: 6 Months
new intracranial hemorrhage rate
The safety of both procedures will be measured in terms of new intracranial hemorrhage
Measured: 6 Months
tension pneumocephalus
The safety of both procedures will be measured in terms of tension pneumocephalus
Measured: 6 Months
mortality
The safety of both procedures will be measured in terms of mortality
Measured: 6 Months
morbidity
The safety of both procedures will be measured in terms of morbidity
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start1 Apr 2017 (estimated)
- Primary completion30 Sep 2019 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saleh Almenawer, Hamilton Health Sciences Corporation
- Investigators
- Saleh Almenawer, MD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053895
- Sponsor's protocol ID
- 19122016
- Acronym
- DECIDE
- Status last verified
- Feb 2017
- First submitted
- 26 Dec 2016
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Versus Operating Room Burr-Hole Drainage of Chronic Subdural Hematoma (DECIDE)
- ClinicalTrials.gov ID
- NCT03053895
- Acronym / sponsor ID
- DECIDE / 19122016
- Conditions
- Chronic Subdural Hematoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 486 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 1 Apr 2017 (estimated)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DECIDE (Bedside versus Operating Room Burr-Hole DrainagE of ChronIc SubDural HEmatoma)
CSDH is an abnormal collection of blood between the layers of the brain causing brain tissue compression leading to neurological complications. One of the most common risk factors contributing to CSDH is head trauma, which is usually in the form of a minor head injury. Older individuals are at increased risk of CSDH due to brain atrophy that occurs with advancing age as well as their tendency to fall and sustain minor head traumas. Chronic alcoholics are also at increased risk as alcoholism also leads to brain atrophy, increased risk of falls, and liver failure which results in increased bleeding risk. Also many drugs used today like anticoagulants, antithrombotics, and antiplatelets for certain health conditions are other common risk factors for CSDH.
The overall goal of this multi-centered trial in the USA and Canada is to assess the surgical management of chronic subdural hematoma (CSDH) and to demonstrate the effectiveness of bedside drainage and its safety as it bypasses the perioperative risk associated with anesthetic especially among the elderly.
Adult patients with a clear indication for CSDH drainage will be randomly assigned to one of two procedures. One group will receive the twist drill procedure which can be performed at the bedside. The second group will undergo the burr-hole drainage procedure in the operating room usually under general anesthetic. Typically, the twist drill procedure can occur sooner as the operating room and Anesthetist are not required. Reoccurrence of the CSDH will be assessed over a period of 6 months following drainage. Timing of procedure, risk of infection, adverse side effects and neurological functioning will also be measured.
Over a 3 year study period, 486 eligible patients (243 patients per arm) will be enrolled. Patients > 18 years with confirmed diagnosis of symptomatic CSDH will be provided one of the two procedures and will be followed for study outcomes at 1, 3 and 6 months following the procedure.
Primary analysis will be to compare the surgical procedures, assessing the recurrence rate of CSDH within 6 months of initial CSDH drainage.
The ultimate goal of this study is to standardize bedside drainage as the treatment of choice for CSDH management.
This trial is important in the ongoing search for more efficient and safe intervention strategies.
Detailed description
DECIDE (Bedside versus Operating Room Burr-Hole DrainagE of ChronIc SubDural HEmatoma)
Background and Significance: Chronic subdural hematoma (CSDH) is an abnormal collection of liquefied blood products between the dura and arachnoid membranes of the brain that may cause brain tissue compression and subsequent neurological sequelae. One of the most common risk factors contributing to CSDH is head trauma, which is usually in the form of a minor head injury. Older individuals are at increased risk of CSDH due to brain atrophy that occurs with advancing age as well as their tendency to fall and sustain minor head traumas. Chronic alcoholics are also at increased risk as alcoholism leads to globalized brain atrophy, increased risk of falls, and hepatogenic coagulopathy. Coagulopathies including the use of anticoagulants, antithrombotics, and antiplatelets for certain health conditions are other common risk factors for CSDH.
Study Aims: The primary aim of our study is to conduct a high-quality randomized trial to compare the safety and effectiveness of the bedside and operating room burr-hole drainage of CSDH. The main objective of this study is to demonstrate the effectiveness of bedside drainage and its safety as it bypasses the perioperative risk associated with anesthetic especially among the elderly.
The ultimate goal of this study is to standardize bedside drainage as the treatment of choice for CSDH management.
Primary Objective: To assess the efficacy of bedside drainage compared to operating room burr-hole evacuation for CSDH management by examining the hypothesis that bedside is associated with lower recurrence rate.
Secondary Objectives: To examine if the bedside drainage and the operating room burr-hole drainage are efficacious in terms of functional outcomes. To evaluate the hypothesis that bedside drainage is safer compared to the operating room burr-hole drainage by measuring mortality and morbidity.
Overall study design: Multi-centered pragmatic randomized controlled trial across North America (USA and Canada) comparing bedside drainage with operating room burr-hole drainage of CSDH.
Duration: Over a 3 year study period, each patient will be followed for 6 months to measure the study outcomes.
Study population: The study population will include 486 eligible patients >18 years of age with confirmed diagnosis of symptomatic CSDH (243 patients per arm).
Inclusion Criteria: Patients aged > 18 years presenting with symptomatic CSDH confirmed on diagnostic imaging, who are able to provide informed consent or have a legal representatives available if unable to do so.
Main intervention and comparator(s): Patients will be randomly assigned between the two arms of the study, bedside and operating room burr-hole drainage. For patients randomized to bedside drainage of CSDH, the twist-drill procedure will be conducted at the patient's bedside using local anesthetic. For patients randomized to burr-hole drainage, the procedure will be performed in the operating room under local or general anesthesia based on the surgeon's and anesthesiologist's judgement of the clinical stability of the patient. Randomization via www.randomize.net website will be stratified by center and by patient age in variable unspecified block sizes.
Follow-Up Post-Randomization: Patients randomized will be followed for study outcomes on days 1, 2, discharge, and months 1, 3 and 6.
Primary Outcome: The efficacy of comparative surgical procedures will be measured by the recurrence rate of CSDH within 6 months of initial CSDH drainage.
Secondary Functional Outcomes: Postoperative neurological and functional status of the patients will be measured using the Markwalder Grading System (MGS), Glasgow Outcome Score (GOS), and modified Rankin Scale (MRS).
Secondary Safety Outcomes: The safety of both procedures will be measured in terms of mortality and morbidity including surgical site infections, misplacement of postoperative subdural drain, tension pneumocephalus, new intracranial hemorrhage, and other medical complications.
Sample Size: Sample size estimation is based on a Chi-squared two-sided test of the null hypothesis that bedside drainage is not different from burr-hole drainage in reducing the proportion of patients who experience a hematoma recurrence within 6 months of the drainage procedure. Including for possible attrition rate of 10% a total of 486 patients (243 per arm) will be required to detect a difference in recurrence rates of 7% or a risk ratio of 0.36 (11% in the burr-hole group and 4% in the bedside drainage group), with a power of 80% and a level of significance set at alpha=0.05.
Primary Analysis: Primary analysis will be by intention-to-treat and data analyst will be blinded to participant allocation.
Interim Analyses: Interim analyses will be conducted upon recruitment of 25% of the expected sample size (122 patients) to assess recruitment rates, recurrence rates and safety outcomes.
This trial is important in the ongoing search for more efficient and safe intervention strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSDH Bedside twist drill technique | Experimental | Procedure: CSDH - Bedside twist drill techniqueFor patients randomized to bedside drainage of Chronic Subdural Hematoma, the twist-drill procedure will be conducted at the patient's bedside using local anesthetic. |
| CSDH Operating Room Burr-hole technique | Active comparator | Procedure: CSDH - Operating Room Burr-hole techniqueFor patients randomized to burr-hole drainage, the procedure will be performed in the operating room under local or general anesthesia based on the surgeon's and anesthesiologist's judgement of the clinical stability of the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged >/= 18 years
- Presenting with symptomatic Chronic Subdural Hematoma confirmed on diagnostic imaging
- Able to provide informed consent or have a legal representatives available if unable to do so
Key exclusion criteria (7 listed)
- Patients with acute or subacute subdural hematoma
- Patients with incidental or asymptomatic findings on CT; skull base, posterior fossa, or in the inter-hemispheric fissure Chronic Subdural Hematoma
- Patients with recurrent hematoma within 6 months of initial drainage
- Patients with Chronic Subdural Hematoma from previous intracranial surgery for different pathology Patients with subdural hygroma and non-hairline skull fracture over the Chronic Subdural Hematoma
- Patients with significant cognitive impairment or severe co-morbidity preventing improvement or follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSDH - Bedside twist drill techniqueFor patients randomized to bedside drainage of CSDH, the twist-drill procedure will be conducted at the patient's bedside using local anesthetic | Procedure or surgery | CSDH Bedside twist drill technique |
| CSDH - Operating Room Burr-hole techniqueFor patients randomized to burr-hole drainage, the procedure will be performed in the operating room under local or general anesthesia based on the surgeon's and anesthesiologist's judgement of the clinical stability of the patient. | Procedure or surgery | CSDH Operating Room Burr-hole technique |
Primary outcome
Recurrence rate of Chronic Subdural Hematoma
Time frame: 6 months
9 secondary outcomes
Postoperative neurological and functional status - MGS
Time frame: 6 Months
Postoperative neurological and functional status - GOS
Time frame: 6 Months
Postoperative neurological and functional status - MRS
Time frame: 6 Months
surgical site infection rate
Time frame: 6 Months
safety - misplacement of postoperative subdural drain
Time frame: 6 Months
new intracranial hemorrhage rate
Time frame: 6 Months
tension pneumocephalus
Time frame: 6 Months
mortality
Time frame: 6 Months
morbidity
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saleh Almenawer, MD principal investigator
Hamilton Health Sciences Corporation
Questions about this trial
What is this clinical trial studying?
A study testing CSDH - Bedside twist drill technique and CSDH - Operating Room Burr-hole technique in people with Chronic Subdural Hematoma, run by Hamilton Health Sciences Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saleh Almenawer, MD (905-521-2100 ext. 44629, Dr_menawer@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of Chronic Subdural Hematoma (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.