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The purpose of the study is to assess efficacy and safety of HemoStyp as an adjunct for management of secondary hemostasis in the operative setting.
This study is a prospective, non-inferiority, multi-center, randomized, open-label trial to compare HemoStyp with Surgicel® in the management of bleeding during surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HemoStyp | Active Comparator | Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use. |
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| Surgicel | Active Comparator | Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HemoStyp | Device | During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use. |
| Measure | Description | Time Frame |
|---|---|---|
| The Time to Hemostasis Measured From Start of Study Treatment to the Achievement of Hemostasis at the Target Bleeding Site (TBS), or to the End of the 10-minute Observation Period. | The time to hemostasis was measured from start of study treatment to the achievement of hemostasis at the target bleeding site (TBS), or to the end of the 10-minute observation period. The time to hemostasis was considered as censored at the end of the 10-minute observation period. Time to hemostasis was quantified in minutes according to its nominal time point. When re-bleeding occurred, and the cessation of bleeding is again achieved at a later time point, the effective time to hemostasis was the latter time point. The time to hemostasis was the time from start of study treatment to that last effective hemostatic time point. | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes | Percentage of subjects achieving hemostasis at the target bleeding site at 2 minutes, 5 minutes and 10 minutes following the start of study treatment. | Between 2 minutes and 10 minutes |
| Rate of Subjects Achieving Intraoperative Hemostasis at the Target Bleeding Site |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raymond Schaerf | Burbank | California | 91505 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | HemoStyp | Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use. HemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use. |
| FG001 | Surgicel | Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use. Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | HemoStyp | Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use. HemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Time to Hemostasis Measured From Start of Study Treatment to the Achievement of Hemostasis at the Target Bleeding Site (TBS), or to the End of the 10-minute Observation Period. | The time to hemostasis was measured from start of study treatment to the achievement of hemostasis at the target bleeding site (TBS), or to the end of the 10-minute observation period. The time to hemostasis was considered as censored at the end of the 10-minute observation period. Time to hemostasis was quantified in minutes according to its nominal time point. When re-bleeding occurred, and the cessation of bleeding is again achieved at a later time point, the effective time to hemostasis was the latter time point. The time to hemostasis was the time from start of study treatment to that last effective hemostatic time point. | Posted | Median | 95% Confidence Interval | seconds | 10 minutes |
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From treatment to 30 days.
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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 | HemoStyp | Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use. HemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment | Patient had pneumonia requiring hospitalization, not related to the study treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment | Abdominal pain that resolved. Not related to the study treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Abate, MD Chief Medical Officer | United Health Products, Inc. | (386) 627-1598 | G.Abate@unitedhealthproductsinc.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 | Jul 2, 2019 | Nov 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Surgicel | Device | During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use. |
|
Percentage of subjects with intraoperative hemostasis at the target bleeding site during the intraoperative period. The intraoperative period started when the first cut was made to the patient and ended when the operative field was closed and dressed. |
| Intraoperative period |
| Rate of Subjects With Intraoperative Re-bleeding From the Target Bleeding Site | Percentage of subjects with intraoperative re-bleeding from the target bleeding site post hemostasis | Intraoperative period post hemostasis |
| Rate of Subjects Requiring Surgical Re-exploration up to 30 Days After Surgery for Re-bleeding From the Target Bleeding Site | Postoperative re-bleeding from the target bleeding site requiring surgical re exploration up to 30 days after surgery. | 30 days |
| BG001 | Surgicel | Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use. Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Heart Rate | Mean | Standard Deviation | Beats Per minute |
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| Hemoglobin | Mean | Standard Deviation | grams per deciliter |
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| Hematocrit | Mean | Standard Deviation | percentage |
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| Platelet Count | Mean | Standard Deviation | platelets per micro liter of blood |
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| Type of Surgery | Count of Participants | Participants |
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| Lewis Bleeding Scale Grade | Investigator rated the intensity of the bleeding at the target bleeding site (TBS) according to the validated bleeding scale (Lewis 2017) shown below. Lewis Bleeding Scale Description: Grade 1 is an ooze or intermittent flow with capillary-like bleeding, described as mild bleeding with >1.0-5.0 milliliters per minutes (ML/Min) blood loss. Grade 2 is a continuous flow, venule and arteriolar-like bleeding described as moderate bleeding with >5.0-10.0 ML/Min blood loss | Count of Participants | Participants |
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| OG001 | Surgicel | Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use. Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use. |
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| Secondary | Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes | Percentage of subjects achieving hemostasis at the target bleeding site at 2 minutes, 5 minutes and 10 minutes following the start of study treatment. | Posted | Count of Participants | Participants | Between 2 minutes and 10 minutes |
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|
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| Secondary | Rate of Subjects Achieving Intraoperative Hemostasis at the Target Bleeding Site | Percentage of subjects with intraoperative hemostasis at the target bleeding site during the intraoperative period. The intraoperative period started when the first cut was made to the patient and ended when the operative field was closed and dressed. | Posted | Count of Participants | Participants | Intraoperative period |
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| Secondary | Rate of Subjects With Intraoperative Re-bleeding From the Target Bleeding Site | Percentage of subjects with intraoperative re-bleeding from the target bleeding site post hemostasis | 6 subjects in the Surgicel cohort could not be analyzed because hemostasis was never obtained at the target bleeding site. | Posted | Count of Participants | Participants | Intraoperative period post hemostasis |
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| Secondary | Rate of Subjects Requiring Surgical Re-exploration up to 30 Days After Surgery for Re-bleeding From the Target Bleeding Site | Postoperative re-bleeding from the target bleeding site requiring surgical re exploration up to 30 days after surgery. | 3 subjects in the HemoStyp cohort and 6 subjects in the Surgicel cohort did not finish the 30 day follow up so they were not included in the analysis population. | Posted | Count of Participants | Participants | 30 days |
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| 3 |
| 118 |
| 1 |
| 118 |
| 0 |
| 118 |
| EG001 | Surgicel | Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use. Surgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use. | 1 | 118 | 0 | 118 | 4 | 118 |
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| Soft Tissue infection | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Non-systematic Assessment | Necrotizing soft tissue infection at site of surgery, requiring abdominal wall debridement. Not related to the study treatment. |
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| Pelvic Pain | Reproductive system and breast disorders | MedDRA (10.0) | Non-systematic Assessment | Pelvic Pain resolved, not related to the study treatment. |
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| Bleeding Anterior Venous Fistula | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment | Bleeding of anterior venous fistula, not in the area of the treatment and not related to the study device. |
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| Seroma | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment | Seroma not related to the study treatment. |
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| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment | Constipation not related to the study treatment. |
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| 10 minutes |
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