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Product supplier change - bought out. Unable to enroll patients.
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| Name | Class |
|---|---|
| King Pharmaceuticals is now a wholly owned subsidiary of Pfizer | INDUSTRY |
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Epistaxis is a common problem among people of all ages and backgrounds. However, occasionally epistaxis can be severe enough to require emergency room admission. Among the treatment options for epistaxis, nasal packing is the most common approach. This approach requires a return visit to the clinic for removal of the packing. Additionally, there is a great deal of pain during the insertion and removal of this packing. This study aims to justify the further investigation of thrombin as a potential treatment approach for these patients. Thrombin could provide a treatment approach that reduces pain and eliminates the need for a return visit to the clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Thrombin-JMI |
|
| 2 | Active Comparator | Merocel pack |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrombin-JMI | Drug | 5,000 IU, to nasal mucosa via syringe spray applicator |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cessation of Epistaxis | baseline, day 4-6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith Sale, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Merocel Pack | Standard of care for persons being treated for epistaxis. Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps |
| FG001 | Thrombin-JMI | Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment |
|
| ||||||||||||||||||
| Treatment Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Merocel Pack | Standard of care for persons being treated for epistaxis. Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps |
| BG001 | Thrombin-JMI |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number |
| 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 | Cessation of Epistaxis | No participants started treatment on this study. Study was closed before any study related procedures were administered. | Posted | baseline, day 4-6 |
|
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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 | Merocel Pack | Standard of care for persons being treated for epistaxis. Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Sykes, PhD | University of Kansas Medical Center | 913-588-7154 | ksykes@kumc.edu |
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| ID | Term |
|---|---|
| D004844 | Epistaxis |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006470 | Hemorrhage |
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| ID | Term |
|---|---|
| D013917 | Thrombin |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Merocel pack |
| Drug |
8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps |
|
| NOT COMPLETED |
|
Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Thrombin-JMI | Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator | 0 | 0 | 0 | 0 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |