Trial Outcomes & Findings for Ventriculostomies in SAH: ICP Open or Not? (NCT NCT00787020)

NCT ID: NCT00787020

Last Updated: 2015-11-03

Results Overview

Cerebral artery vasospasm is defined as transcranial doppler mean velocity greater than 120 or angiographic vasospasm determined by cerebral angiogram.

• Recruitment status: COMPLETED
• Target enrollment: 37 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2015-11-03

Participant Flow

Participant milestones

Measure	Ventriculostomy Open Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.	Ventriculostomy Monitored Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
Overall Study STARTED	24	13
Overall Study COMPLETED	24	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ventriculostomies in SAH: ICP Open or Not?

Baseline characteristics by cohort

Measure	Ventriculostomy Open n=24 Participants Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.	Ventriculostomy Monitored n=13 Participants Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.	Total n=37 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	20 Participants n=5 Participants	10 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Continuous	55.92 years STANDARD_DEVIATION 13.35 • n=5 Participants	53.13 years STANDARD_DEVIATION 11.13 • n=7 Participants	54.11 years STANDARD_DEVIATION 11.85 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	13 participants n=7 Participants	37 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Cerebral artery vasospasm is defined as transcranial doppler mean velocity greater than 120 or angiographic vasospasm determined by cerebral angiogram.

Outcome measures

Measure	Ventriculostomy Open n=24 Participants Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.	Ventriculostomy Monitored n=13 Participants Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
Cerebral Artery Vasospasm	16 Participants	7 Participants

SECONDARY outcome

Timeframe: 14 Days

External ventricular drain complications are defined as ventriculitis, shunt dependency, ventricular catheter obstruction requiring manipulation, or removal by the patient.

Outcome measures

Measure	Ventriculostomy Open n=24 Participants Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.	Ventriculostomy Monitored n=13 Participants Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
External Ventricular Drain (EVD) Complications	14 Participants	4 Participants

SECONDARY outcome

Timeframe: 14 Days

Outcome measures

Measure	Ventriculostomy Open n=24 Participants Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.	Ventriculostomy Monitored n=13 Participants Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
Cerebrospinal Fluid (CSF) Output Per Day	134 Milliliter Interval 116.9 to 151.1	135 Milliliter Interval 112.2 to 157.8

Adverse Events

Ventriculostomy Open

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ventriculostomy Monitored

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

DaiWai M Olson

Duke University Medical Center

Phone: 9196683751

Email: Olson006@mc.duke.edu

Results disclosure agreements

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