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Role of Dexamethasone in the Conservative Treatment of Chronic Subdural Hematoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02362321
Recruitment Status : Terminated (Due to serious adverse events)
First Posted : February 12, 2015
Results First Posted : February 27, 2015
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hematoma, Subdural, Chronic
Interventions Drug: Dexamethasone
Other: Placebo
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dexamethasone Control
Hide Arm/Group Description

Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).

Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).

Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
Period Title: Overall Study
Started 10 10
Completed 6 10
Not Completed 4 0
Arm/Group Title Dexamethasone Control Total
Hide Arm/Group Description

Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).

Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).

Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days. Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  10.0%
3
  30.0%
4
  20.0%
>=65 years
9
  90.0%
7
  70.0%
16
  80.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
72.3  (6.3) 69.4  (8.8) 70.9  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
0
   0.0%
2
  20.0%
2
  10.0%
Male
10
 100.0%
8
  80.0%
18
  90.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Rate of Need for Surgery Drainage
Hide Description The rate of success of conservative management was defined as the number of patients not requiring surgery in each treatment group during the 6 months following enrollment.
Time Frame Within 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexamethasone Control
Hide Arm/Group Description:

Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).

Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).

Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: participants
9 7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dexamethasone Control
Hide Arm/Group Description

Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).

Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).

Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
All-Cause Mortality
Dexamethasone Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Dexamethasone Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/10 (80.00%)      2/10 (20.00%)    
Blood and lymphatic system disorders     
Cellulitis *  1/10 (10.00%)  1 0/10 (0.00%)  0
Cardiac disorders     
High pressure   1/10 (10.00%)  1 0/10 (0.00%)  0
Endocrine disorders     
Hyperglycemia   4/10 (40.00%)  4 1/10 (10.00%)  1
Psychiatric disorders     
Suicide *  1/10 (10.00%)  1 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolus *  0/10 (0.00%)  0 1/10 (10.00%)  1
Pulmonary edema *  1/10 (10.00%)  1 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dexamethasone Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Principal Investigator
Organization: CHU de Québec
Phone: 418-649-0252
EMail: michel.prudhomme.chuq@gmail.com
Layout table for additonal information
Responsible Party: CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02362321    
Other Study ID Numbers: PEJ-370
First Submitted: February 9, 2015
First Posted: February 12, 2015
Results First Submitted: February 12, 2015
Results First Posted: February 27, 2015
Last Update Posted: February 29, 2016