Study Stopped
PI left institution prior to study completion
Quality Control: A Prospective Analysis of EVD Effectiveness
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose and/or hypothesis: To decrease the amount of external ventricular drain (EVD) related catheter infections by comparing the efficacy of Oklahoma University Medicine standard EVD catheters, both impregnated and non-impregnated, in three principle areas: incidence of infection, cost analysis, and average durations of placement, all while maintaining the standards of technique.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2015
CompletedFirst Posted
Study publicly available on registry
June 29, 2015
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2018
CompletedResults Posted
Study results publicly available
July 3, 2023
CompletedJuly 3, 2023
June 1, 2023
2.3 years
June 23, 2015
November 4, 2021
June 12, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Infection Rates of EVD Patients
Infection rates of EVD patients
24 months
Other Outcomes (2)
Duration of EVD Placement
24 Months
Cost
24 months
Study Arms (3)
Integra External Drainage Catheter
ACTIVE COMPARATORThe Integra External Drainage Catheter non antibiotic-impregnated EVD catheter
Ventriclear EVD Antibiotic Catheter
ACTIVE COMPARATORThe Ventriclear EVD Antibiotic Catheter antibiotic-impregnated EVD catheter
Codman Bactiseal EVD Catheter Set
ACTIVE COMPARATORThe Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter
Interventions
Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
Eligibility Criteria
You may qualify if:
- Patients who require placement of external ventricular drain.
You may not qualify if:
- Prisoners and/or those who may be pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104, United States
Related Publications (6)
Bohnstedt BN, Ziemba-Davis M, Edwards G, Brom J, Payner TD, Leipzig TJ, Scott JA, DeNardo AJ, Palmer E, Cohen-Gadol AA. Treatment and outcomes among 102 posterior inferior cerebellar artery aneurysms: a comparison of endovascular and microsurgical clip ligation. World Neurosurg. 2015 May;83(5):784-93. doi: 10.1016/j.wneu.2014.12.035. Epub 2014 Dec 23.
PMID: 25541085BACKGROUNDLane B, Bohnstedt BN, Cohen-Gadol AA. A prospective comparative study of microscope-integrated intraoperative fluorescein and indocyanine videoangiography for clip ligation of complex cerebral aneurysms. J Neurosurg. 2015 Mar;122(3):618-26. doi: 10.3171/2014.10.JNS132766. Epub 2014 Dec 19.
PMID: 25526265BACKGROUNDKulwin C, Bohnstedt BN, Payner TD, Leipzig TJ, Scott JA, DeNardo AJ, Cohen-Gadol AA. Aneurysmal acute subdural hemorrhage: prognostic factors associated with treatment. J Clin Neurosci. 2014 Aug;21(8):1333-6. doi: 10.1016/j.jocn.2013.12.010. Epub 2014 Jan 24.
PMID: 24679648BACKGROUNDZiemba-Davis M, Bohnstedt BN, Payner TD, Leipzig TJ, Palmer E, Cohen-Gadol AA. Incidence, epidemiology, and treatment of aneurysmal subarachnoid hemorrhage in 12 midwest communities. J Stroke Cerebrovasc Dis. 2014 May-Jun;23(5):1073-82. doi: 10.1016/j.jstrokecerebrovasdis.2013.09.010. Epub 2013 Oct 19.
PMID: 24144595BACKGROUNDCohen-Gadol AA, Bohnstedt BN. Recognition and evaluation of nontraumatic subarachnoid hemorrhage and ruptured cerebral aneurysm. Am Fam Physician. 2013 Oct 1;88(7):451-6.
PMID: 24134085BACKGROUNDBohnstedt BN, Nguyen HS, Kulwin CG, Shoja MM, Helbig GM, Leipzig TJ, Payner TD, Cohen-Gadol AA. Outcomes for clip ligation and hematoma evacuation associated with 102 patients with ruptured middle cerebral artery aneurysms. World Neurosurg. 2013 Sep-Oct;80(3-4):335-41. doi: 10.1016/j.wneu.2012.03.008. Epub 2012 Mar 30.
PMID: 22465372BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Recruitment was halted prematurely, due to changes in key study personnel. PI left prior to completing final data analysis.
Results Point of Contact
- Title
- Blair Apple
- Organization
- University of Oklahoma Health Science Center
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed A Cheema, MD
Associate Professor
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2015
First Posted
June 29, 2015
Study Start
April 1, 2016
Primary Completion
July 12, 2018
Study Completion
July 12, 2018
Last Updated
July 3, 2023
Results First Posted
July 3, 2023
Record last verified: 2023-06