Trial Outcomes & Findings for Comparison of EVD Catheter Diameter on Occlusion and Replacement (NCT NCT03248739)

Last Updated: 2023-10-25

Results Overview

This is defined by a non-functioning (non-patent) EVD where patency cannot be restored through catheter manipulation or flushing.

Recruitment status

TERMINATED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

Up to 4 weeks

Results posted on

2023-10-25

Participant Flow

33 subjects were consented to study with 33 being randomized.

Participant milestones

Participant milestones
Measure	Large Bore Catheter Group Large Bore Catheter (1.9mmID)	Small Bore Catheter Group Small Bore Catheter (1.5mm ID)
Overall Study STARTED	17	16
Overall Study COMPLETED	17	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of EVD Catheter Diameter on Occlusion and Replacement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Large n=17 Participants Large Bore Catheter (1.9mmID)	Small n=16 Participants Small Bore Catheter (1.5mm ID)	Total n=33 Participants Total of all reporting groups
Age, Continuous	58.8 years STANDARD_DEVIATION 13.9 • n=5 Participants	62.1 years STANDARD_DEVIATION 13.1 • n=7 Participants	60.5 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	16 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 weeks

Population: Randomized to Large or Small Bore Catheters

This is defined by a non-functioning (non-patent) EVD where patency cannot be restored through catheter manipulation or flushing.

Outcome measures

Outcome measures
Measure	Large n=17 Participants Large Bore Catheter (1.9mmID)	Small n=16 Participants Small Bore Catheter (1.5mm ID)
Number of Participants With Permanent Catheter Occlusions	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 4 weeks

Defined by replacement of the ipsilateral EVD due to permanent occlusion, or placement of a contralateral EVD in the setting of a non-functioning ipsilateral catheter. Catheters placed contralaterally in the setting of a functioning ipsilateral catheter will not be considered replacements.

Outcome measures

Outcome measures
Measure	Large n=17 Participants Large Bore Catheter (1.9mmID)	Small n=16 Participants Small Bore Catheter (1.5mm ID)
Number of Participants With Catheter Replacements	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 4 weeks

Defined by non-functioning (non-patent) catheter requiring neurosurgeon flushing or manipulation in order to restore patency. By definition, such maneuvers must restore patency of the EVD such that it is functioning normally afterwards. Multiple temporary occlusions may be possible.

Outcome measures

Outcome measures
Measure	Large n=17 Participants Large Bore Catheter (1.9mmID)	Small n=16 Participants Small Bore Catheter (1.5mm ID)
Number of Participants With Temporary Occlusions	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 hours after placement.

Presence of new catheter-related intraparenchymal hemorrhage, subdural hematoma, or intraventricular hemorrhage on CT scan 48 hours after placement.

Outcome measures

Outcome measures
Measure	Large n=17 Participants Large Bore Catheter (1.9mmID)	Small n=16 Participants Small Bore Catheter (1.5mm ID)
Number of Participants With Procedure-related Hemorrhages	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 4 weeks

Presence of new neurologic deficits as a result of EVD-related hemorrhage, or resulting in need for further procedures due to new EVD-related hemorrhage (craniotomy for hematoma evacuation, ICP monitoring, etc).

Outcome measures

Outcome measures
Measure	Large n=17 Participants Large Bore Catheter (1.9mmID)	Small n=16 Participants Small Bore Catheter (1.5mm ID)
Number of Participants With Symptomatic Hemorrhages	0 Participants	0 Participants

Adverse Events

Large

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Small

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

Kyle Fargen

Wake Forest University School of Medicine

Phone: 336-716-8641

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place