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PI left institution prior to study completion
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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.
Experimental design: Track external ventricular drain (EVD) associated infections and through quality prospective analysis and compare the usage of standard catheters used by the department here at Oklahoma University, 1) the 35cm Codman Bactiseal rifampin and clindamycin impregnated catheter, 2) the Ventriclear EVD Antibiotic Catheter, and 3) the 36 cm Integra Hermatic large style ventricular catheter, in terms of incidence of infections, cost, duration of placement, and differences in placement technique.
Proposed procedure: Monitor for infections associated with and related to EVD placement in patients and assess if infections rates are affected by usage of antibiotic impregnated EVD catheters.
Importance of knowledge reasonably expected to result from the research: While use of sterile techniques and periprocedural antibiotics have traditionally been used to combat infection, infection rates remain above goal leading to the question of whether the antibiotic impregnated catheter should be added to the standard of care. With the knowledge gained, the investigators hope to decrease the amount of external ventricular drain related catheter infections and reduce use of prolonged antibiotics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integra External Drainage Catheter | Active Comparator | The Integra External Drainage Catheter non antibiotic-impregnated EVD catheter |
|
| Ventriclear EVD Antibiotic Catheter | Active Comparator | The Ventriclear EVD Antibiotic Catheter antibiotic-impregnated EVD catheter |
|
| Codman Bactiseal EVD Catheter Set | Active Comparator | The Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Integra External Drainage Catheter. | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Infection Rates of EVD Patients | Infection rates of EVD patients | 24 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Duration of EVD Placement | duration of EVD placement in days | 24 Months |
| Cost | Comparable cost of each device | 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed A Cheema, MD | Associate Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma University Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25541085 | Background | 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. | |
| 25526265 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ventriclear EVD Antibiotic Catheter | The Ventriclear EVD Antibiotic Catheter antibiotic-impregnated EVD catheter The Ventriclear EVD Antibiotic Catheter: 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. |
| FG001 | Integra External Drainage Catheter | The Integra External Drainage Catheter non antibiotic-impregnated EVD catheter The Integra External Drainage Catheter.: 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. |
| FG002 | Codman Bactiseal EVD Catheter Set | The Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter The Codman Bactiseal EVD Catheter Set: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ventriclear EVD Antibiotic Catheter | The Ventriclear EVD Antibiotic Catheter antibiotic-impregnated EVD catheter The Ventriclear EVD Antibiotic Catheter: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Infection Rates of EVD Patients | Infection rates of EVD patients | Posted | Count of Participants | Participants | 24 months |
|
Up to 90 days (admission to discharge)
Adverse events, specifically infections due to EVD were collected while participant was in the hospital.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Integra External Drainage Catheter | The Integra External Drainage Catheter non antibiotic-impregnated EVD catheter The Integra External Drainage Catheter.: 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. |
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Recruitment was halted prematurely, due to changes in key study personnel. PI left prior to completing final data analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Blair Apple | University of Oklahoma Health Science Center | 4052714658 | 1 | Blair-Apple@ouhsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2019 | Jun 1, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055499 | Catheter-Related Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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| The Ventriclear EVD Antibiotic Catheter | Device | 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. |
|
| The Codman Bactiseal EVD Catheter Set | Device | 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. |
|
| Lane 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. |
| 24679648 | Background | Kulwin 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. |
| 24144595 | Background | Ziemba-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. |
| 24134085 | Background | Cohen-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. |
| 22465372 | Background | Bohnstedt 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. |
| BG001 | Integra External Drainage Catheter | The Integra External Drainage Catheter non antibiotic-impregnated EVD catheter The Integra External Drainage Catheter.: 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. |
| BG002 | Codman Bactiseal EVD Catheter Set | The Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter The Codman Bactiseal EVD Catheter Set: 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Codman Bactiseal EVD Catheter Set | The Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter The Codman Bactiseal EVD Catheter Set: 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. |
|
|
| Other Pre-specified | Duration of EVD Placement | duration of EVD placement in days | Posted | Mean | Standard Deviation | days | 24 Months |
|
|
|
| Other Pre-specified | Cost | Comparable cost of each device | This data was not collected and is no longer available. | Posted | 24 months |
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Ventriclear EVD Antibiotic Catheter | The Ventriclear EVD Antibiotic Catheter antibiotic-impregnated EVD catheter The Ventriclear EVD Antibiotic Catheter: 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. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Codman Bactiseal EVD Catheter Set | The Codman Bactiseal EVD Catheter Set antibiotic-impregnated EVD catheter The Codman Bactiseal EVD Catheter Set: 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. | 0 | 19 | 0 | 19 | 0 | 19 |
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