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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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.

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 draina
Sponsor: Hamilton Health Sciences Corporation

Current Primary Outcome: Recurrence rate of Chronic Subdural Hematoma [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Postoperative neurological and functional status - MGS [ Time Frame: 6 Months ]
  Postoperative neurological and functional status using Markwalder Grading System
• Postoperative neurological and functional status - GOS [ Time Frame: 6 Months ]
  Postoperative neurological and functional status using Glasgow Outcome Score
• Postoperative neurological and functional status - MRS [ Time Frame: 6 Months ]
  Postoperative neurological and functional status using modified Rankin Scale
• surgical site infection rate [ Time Frame: 6 Months ]
  The safety of both procedures will be measured in terms of surgical site infections
• safety - misplacement of postoperative subdural drain [ Time Frame: 6 Months ]
  The safety of both procedures will be measured in terms of misplacement of postoperative subdural drain
• new intracranial hemorrhage rate [ Time Frame: 6 Months ]
  The safety of both procedures will be measured in terms of new intracranial hemorrhage
• tension pneumocephalus [ Time Frame: 6 Months ]
  The safety of both procedures will be measured in terms of tension pneumocephalus
• mortality [ Time Frame: 6 Months ]
  The safety of both procedures will be measured in terms of mortality
• morbidity [ Time Frame: 6 Months ]
  The safety of both procedures will be measured in terms of morbidity

Original Secondary Outcome: Same as current

Information By: Hamilton Health Sciences Corporation

Dates:
Date Received: December 26, 2016
Date Started: April 1, 2017
Date Completion: February 28, 2020
Last Updated: February 12, 2017
Last Verified: February 2017