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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1185-5780 | Other Identifier | World Health Organization | |
| CTRI/2016/07/007115 | Registry Identifier | Clinical Trial Registry - India |
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To evaluate Safety and Efficacy of Axiostat® hemostatic dressing in terms of time to achieve hemostasis, post application complication and comfort levels of patients.
To evaluate Safety and Efficacy of Axiostat® hemostatic dressing in terms of time to achieve hemostasis, post application complication and comfort levels of patients who have undergone radial intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axiostat® | Size: 3.5 cm X 3.5 cm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axiostat® | Device | Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Achieve Hemostasis | Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops. Unit of measurement is minutes. | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Quantity of Product Used | Number of Axiostat® required to achieve hemostasis. Unit of measurement is number. | 1 Day |
| Number of Patients With Re-bleeding | Number of patients will be counted (unit of measurement is number/count of patients) with re-bleeding after removal of Axiostat |
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Inclusion Criteria:
Exclusion Criteria:
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All eligible patients who came to the institution/hospital and provided informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Milan Chag, Dr. | Care Institute of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Care Institute of Medical Sciences,Nr. Shukan Mall, Off Science City Road,Sola | Ahmedabad | Gujarat | 380060 | India |
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| ID | Title | Description |
|---|---|---|
| FG000 | Axiostat® | Size: 3.5 cm X 3.5 cm Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Axiostat® | Size: 3.5 cm X 3.5 cm Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Males and Females have been mentioned separately |
| 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 | Time to Achieve Hemostasis | Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops. Unit of measurement is minutes. | Posted | Mean | Standard Deviation | minutes | 1 Day |
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Adverse event data was collected till the patient was discharged.
Any occurrence of adverse event was be recorded on the Adverse Event CRF. The number of patients at risk of adverse event is minimum as the product under evaluation is an approved product and so associated risks are less.
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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 | Axiostat® | Size: 3.5 cm X 3.5 cm Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shailee Mehta, Clinical Research Manager | Axio Biosolutions Pvt. Ltd. | 9879009940 | shailee.m@axiobio.com |
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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 31, 2020 | Jan 1, 2021 | Prot_SAP_000.pdf |
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|
| 1 Day |
| Number of Participants With Allergy/Skin Irritation and Hematoma Formation |
Mode of Measurement for both of the above outcomes is Visual Observation. Skin irritation/Allergy: Occurrence of redness at the puncture site was noted as skin irritation/allergy Hematoma: Hematoma formation at the puncture site. Hematoma was defined as presence of ecchymosis (the escape of blood into the tissues from ruptured blood vessels) at access site. | Upto 2 Days |
| Ease of Use of Product | Level of ease of use of Axiostat was recorded. The ease of application and removal of Axiostat was rated as Excellent or Good or Fair or Poor by the Clinician / Operator Mode of Measurement is Verbal Inquiry. | Upto 2 Days |
| Patient Comfort Level | Patients comfort level for use of dressing was recorded. The patient was required to rate the comfort level of use of dressing in terms of pain and swelling at the puncture site. It was assessed by verbal inquiry and visual observation. | 1 day |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Baseline Blood Pressure | Mean | Standard Deviation | mmHg |
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| Haemoglobin | Mean | Standard Deviation | g/dl |
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| Prior History and Risk Factors | Patients prior medical history was noted after enrollment Count of participants was noted for each parameter | Count of Participants | Participants |
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| Secondary | Quantity of Product Used | Number of Axiostat® required to achieve hemostasis. Unit of measurement is number. | Posted | Number | unit | 1 Day |
|
|
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| Secondary | Number of Patients With Re-bleeding | Number of patients will be counted (unit of measurement is number/count of patients) with re-bleeding after removal of Axiostat | Posted | Count of Participants | Participants | 1 Day |
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|
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| Secondary | Number of Participants With Allergy/Skin Irritation and Hematoma Formation |
Mode of Measurement for both of the above outcomes is Visual Observation. Skin irritation/Allergy: Occurrence of redness at the puncture site was noted as skin irritation/allergy Hematoma: Hematoma formation at the puncture site. Hematoma was defined as presence of ecchymosis (the escape of blood into the tissues from ruptured blood vessels) at access site. | Posted | Count of Participants | Participants | Upto 2 Days |
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|
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| Secondary | Ease of Use of Product | Level of ease of use of Axiostat was recorded. The ease of application and removal of Axiostat was rated as Excellent or Good or Fair or Poor by the Clinician / Operator Mode of Measurement is Verbal Inquiry. | Posted | Count of Participants | Participants | Upto 2 Days |
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|
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| Secondary | Patient Comfort Level | Patients comfort level for use of dressing was recorded. The patient was required to rate the comfort level of use of dressing in terms of pain and swelling at the puncture site. It was assessed by verbal inquiry and visual observation. | Posted | Count of Participants | Participants | 1 day |
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|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
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| Removal |
|
| Title | Measurements |
|---|---|
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| Intolerable swelling & pain |
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