Trial Outcomes & Findings for Chronic Subdural Hematoma - Reduction of Recurrence by Treatment With Angiotensin Converting Enzyme Inhibitors (NCT NCT00915928)

Results Overview

Volume of CSDH remnant three months after evacuation measure using xyz/2 on CT scans

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

3 months

Results posted on

2020-08-19

Participant Flow

Neurosurgical clinic

Participant milestones

Participant milestones
Measure	ACE Inhibitor Perindopril: 2,5 mg daily for 3 months	Placebo Placebo
Overall Study STARTED	25	22
Overall Study COMPLETED	25	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Many patients were not able to consent and the neurosurgeon on call were too busy to include in the project

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=22 Participants three months placebo treatment after surgical CSDH evacuation	Perindopril n=25 Participants three months perindopril treatment after surgical CSDH evacuation	Total n=47 Participants Total of all reporting groups
Age, Continuous	70.5 years STANDARD_DEVIATION 5 • n=5 Participants	64.3 years STANDARD_DEVIATION 5 • n=7 Participants	67.2 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment Denmark	22 participants n=5 Participants • Many patients were not able to consent and the neurosurgeon on call were too busy to include in the project	25 participants n=7 Participants • Many patients were not able to consent and the neurosurgeon on call were too busy to include in the project	47 participants n=5 Participants • Many patients were not able to consent and the neurosurgeon on call were too busy to include in the project
Size of Chronic Subdural Hematoma	130 cm^3 STANDARD_DEVIATION 10 • n=5 Participants	124 cm^3 STANDARD_DEVIATION 10 • n=7 Participants	127 cm^3 STANDARD_DEVIATION 10 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Volume of CSDH remnant three months after evacuation measure using xyz/2 on CT scans

Outcome measures

Outcome measures
Measure	ACE Inhibitor n=25 Participants Perindopril: 2,5 mg daily for 3 months	Placebo n=22 Participants Placebo
Size of Chronic Subdural Hematoma (CSDH)	28.4 cm^3 Standard Deviation 5	22.8 cm^3 Standard Deviation 5

SECONDARY outcome

Timeframe: years

Population: Analysis will not be performed due to insufficient funding and the samples will be destroyed

Post-Hoc Outcome Measure

Outcome measures

Outcome data not reported

Adverse Events

ACE Inhibitor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Frantz Rom Poulsen, Professor, consultant

Odense University Hospital, Odense, Denmark

Phone: 0045 65413600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place