Trial Outcomes & Findings for Role of Dexamethasone in the Conservative Treatment of Chronic Subdural Hematoma (NCT NCT02362321)

NCT ID: NCT02362321

Last Updated: 2016-02-29

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: Within 6 months
• Results posted on: 2016-02-29

Participant Flow

Participant milestones

Measure	Dexamethasone 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).	Control Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
Overall Study STARTED	10	10
Overall Study COMPLETED	6	10
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Role of Dexamethasone in the Conservative Treatment of Chronic Subdural Hematoma

Baseline characteristics by cohort

Measure	Dexamethasone n=10 Participants 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).	Control n=10 Participants Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Age, Continuous	72.3 years STANDARD_DEVIATION 6.3 • n=5 Participants	69.4 years STANDARD_DEVIATION 8.8 • n=7 Participants	70.9 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment Canada	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 6 months

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.

Outcome measures

Measure	Dexamethasone n=10 Participants 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).	Control n=10 Participants Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
Rate of Need for Surgery Drainage	9 participants	7 participants

Adverse Events

Dexamethasone

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dexamethasone n=10 participants at risk 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).	Control n=10 participants at risk Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
Endocrine disorders Hyperglycemia	40.0% 4/10 • Number of events 4	10.0% 1/10 • Number of events 1
Cardiac disorders High pressure	10.0% 1/10 • Number of events 1	0.00% 0/10
Respiratory, thoracic and mediastinal disorders Pulmonary embolus	0.00% 0/10	10.0% 1/10 • Number of events 1
Blood and lymphatic system disorders Cellulitis	10.0% 1/10 • Number of events 1	0.00% 0/10
Respiratory, thoracic and mediastinal disorders Pulmonary edema	10.0% 1/10 • Number of events 1	0.00% 0/10
Psychiatric disorders Suicide	10.0% 1/10 • Number of events 1	0.00% 0/10

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

CHU de Québec

Phone: 418-649-0252

Email: michel.prudhomme.chuq@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place