Bedside Versus Operating Room Burr-Hole Drainage of Chronic Subdural Hematoma (DECIDE)

NCT03053895 | Unknown DMC

• 1 other identifier: 19122016
• Study Type: interventional
• Target: 486
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Chronic Subdural Hematoma

Outcome Measures

Primary Outcomes (1)

• Recurrence rate of Chronic Subdural Hematoma

  6 months

Secondary Outcomes (9)

• Postoperative neurological and functional status - MGS

  6 Months

• Postoperative neurological and functional status - GOS

  6 Months

• Postoperative neurological and functional status - MRS

  6 Months

• surgical site infection rate

  6 Months

• safety - misplacement of postoperative subdural drain

  6 Months

Study Arms (2)

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.

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.

Procedure: CSDH - Operating Room Burr-hole technique

Interventions

CSDH - Bedside twist drill technique PROCEDURE

For patients randomized to bedside drainage of CSDH, the twist-drill procedure will be conducted at the patient's bedside using local anesthetic

CSDH Bedside twist drill technique

CSDH - Operating Room Burr-hole technique PROCEDURE

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.

CSDH Operating Room Burr-hole technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• Saleh Almenawer, MD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh Almenawer, MD

CONTACT

905-521-2100; Dr_menawer@hotmail.com

Nicole Zytaruk, RN

CONTACT

905-522-1155; zytaruk@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon, Division of Neurosurgery, Principal Investigator

Study Record Dates

• First Submitted: December 26, 2016
• First Posted: February 15, 2017
• Study Start: April 1, 2017
• Primary Completion: September 30, 2019
• Study Completion: February 28, 2020
• Last Updated: February 15, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share