Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting

• Sponsor: United Health Products, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03654560
• Collaborator: (none)
• Enrollment: 236
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.5
• Patients Per Site Per Month: 27.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hemostasis; Bleeding	Device: HemoStyp; Device: Surgicel	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 236 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting
• Actual Study Start Date: Dec 28, 2018
• Actual Primary Completion Date: Aug 5, 2019
• Actual Study Completion Date: Sep 12, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: HemoStyp Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.	Device: 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.
Active Comparator: Surgicel Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.	Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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. [10 minutes]

   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.

Secondary Outcome Measures

1. Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes [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.

2. Rate of Subjects Achieving Intraoperative Hemostasis at the Target Bleeding Site [Intraoperative period]

   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.

3. Rate of Subjects With Intraoperative Re-bleeding From the Target Bleeding Site [Intraoperative period post hemostasis]

   Percentage of subjects with intraoperative re-bleeding from the target bleeding site post hemostasis

4. Rate of Subjects Requiring Surgical Re-exploration up to 30 Days After Surgery for Re-bleeding From the Target Bleeding Site [30 days]

   Postoperative re-bleeding from the target bleeding site requiring surgical re exploration up to 30 days after surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Elective procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery);

2. At time of surgery 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;

3. Ages: Pediatric subjects 2 years to 17 years of age and adult subjects 18 years of age or older; and

4. Subjects or parent or legal guardian of the subject who are willing and able to sign consent.

Exclusion Criteria:

1. Physical or psychological condition which would impair study participation;

2. Indications for emergency surgery;

3. Pre-operative laboratory findings of a hematologic disorder;

4. Subjects with history of moderate to severe allergies;

5. Subjects undergoing minimally invasive laparoscopic surgery;

6. Subjects who will require platelet or fresh frozen plasma transfusion during surgery;

7. Subjects who are pregnant or breast-feeding at the time of surgery; or

8. Subjects on P2Y12 platelet inhibitor (Plavix) less than 5 days prior to surgery, warfarin or Xa inhibitors not withheld per standard protocols for the management of anticoagulants pre-operatively.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Raymond Schaerf	Burbank	California	United States	91505

Sponsors and Collaborators

• United Health Products, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 2, 2019

More Information

Publications

None provided.

• Responsible Party: United Health Products, Inc.
• ClinicalTrials.gov Identifier: NCT03654560
• Other Study ID Numbers: UHP001
• First Posted: Aug 31, 2018
• Last Update Posted: Oct 22, 2020
• Last Verified: Oct 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Arm/Group Title	HemoStyp	Surgicel
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	118	118
COMPLETED	114	117
NOT COMPLETED	4	1

Baseline Characteristics

Arm/Group Title	HemoStyp	Surgicel	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	118	118	236
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.89 (16.13)	61.48 (16.48)	60.19 (16.32)
Sex: Female, Male (Count of Participants)
Female	52 44.1%	45 38.1%	97 41.1%
Male	66 55.9%	73 61.9%	139 58.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	31 26.3%	26 22%	57 24.2%
Not Hispanic or Latino	87 73.7%	92 78%	179 75.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	10 8.5%	6 5.1%	16 6.8%
Native Hawaiian or Other Pacific Islander	1 0.8%	1 0.8%	2 0.8%
Black or African American	5 4.2%	3 2.5%	8 3.4%
White	74 62.7%	86 72.9%	160 67.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	28 23.7%	22 18.6%	50 21.2%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	164.84 (19.59)	168.55 (15.5)	166.69 (19.59)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	79.94 (38.62)	86.48 (49.88)	83.24 (38.62)
Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	124.11 (25.14)	124.53 (26.75)	124.26 (26.36)
Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	67.34 (16.87)	67.48 (16.09)	67.45 (16.87)
Heart Rate (Beats Per minute) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Beats Per minute]	71.26 (13.87)	71.89 (13.12)	71.54 (13.67)
Hemoglobin (grams per deciliter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [grams per deciliter]	12.37 (2.83)	12.14 (2.69)	12.25 (2.83)
Hematocrit (percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage]	40.18 (26.52)	36.16 (7.71)	38.15 (26.52)
Platelet Count (platelets per micro liter of blood) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [platelets per micro liter of blood]	212.83 (92.5)	221.81 (99.45)	217.36 (92.5)
Type of Surgery (Count of Participants)
Abdominal Surgery	35 29.7%	37 31.4%	72 30.5%
Thoracic Surgery	32 27.1%	38 32.2%	70 29.7%
Vascular Surgery	51 43.2%	43 36.4%	94 39.8%
Lewis Bleeding Scale Grade (Count of Participants)
Lewis Bleeding Scale Grade 1	61 51.7%	73 61.9%	134 56.8%
Lewis Bleeding Scale Grade 2	57 48.3%	45 38.1%	102 43.2%

Outcome Measures

1. Primary Outcome

Title	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.
Description	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.
Time Frame	10 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HemoStyp	Surgicel
Arm/Group Description	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.	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.
Measure Participants	118	118
Median (95% Confidence Interval) [seconds]	36	67

2. Secondary Outcome

Title	Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes
Description	Percentage of subjects achieving hemostasis at the target bleeding site at 2 minutes, 5 minutes and 10 minutes following the start of study treatment.
Time Frame	Between 2 minutes and 10 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HemoStyp	Surgicel
Arm/Group Description	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.	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.
Measure Participants	118	118
2 minutes	118 100%	96 81.4%
5 minutes	118 100%	110 93.2%
10 minutes	118 100%	112 94.9%

3. Secondary Outcome

Title	Rate of Subjects Achieving Intraoperative Hemostasis at the Target Bleeding Site
Description	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.
Time Frame	Intraoperative period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HemoStyp	Surgicel
Arm/Group Description	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.	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.
Measure Participants	118	118
Count of Participants [Participants]	118 100%	112 94.9%

4. Secondary Outcome

Title	Rate of Subjects With Intraoperative Re-bleeding From the Target Bleeding Site
Description	Percentage of subjects with intraoperative re-bleeding from the target bleeding site post hemostasis
Time Frame	Intraoperative period post hemostasis

Outcome Measure Data

Analysis Population Description

6 subjects in the Surgicel cohort could not be analyzed because hemostasis was never obtained at the target bleeding site.

Arm/Group Title	HemoStyp	Surgicel
Arm/Group Description	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.	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.
Measure Participants	118	112
Count of Participants [Participants]	0 0%	0 0%

5. Secondary Outcome

Title	Rate of Subjects Requiring Surgical Re-exploration up to 30 Days After Surgery for Re-bleeding From the Target Bleeding Site
Description	Postoperative re-bleeding from the target bleeding site requiring surgical re exploration up to 30 days after surgery.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	HemoStyp	Surgicel
Arm/Group Description	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.	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.
Measure Participants	115	112
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	From treatment to 30 days.
Arm/Group Title	HemoStyp		Surgicel
Arm/Group Description	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.		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.
All Cause Mortality
	HemoStyp		Surgicel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/118 (2.5%)		1/118 (0.8%)
Serious Adverse Events
	HemoStyp		Surgicel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/118 (0.8%)		0/118 (0%)
Respiratory, thoracic and mediastinal disorders
Pneumonia	1/118 (0.8%)	1	0/118 (0%)	0
Skin and subcutaneous tissue disorders
Soft Tissue infection	1/118 (0.8%)	1	0/118 (0%)	0
Other (Not Including Serious) Adverse Events
	HemoStyp		Surgicel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/118 (0%)		4/118 (3.4%)
Blood and lymphatic system disorders
Seroma	0/118 (0%)	0	1/118 (0.8%)	1
Gastrointestinal disorders
Abdominal Pain	0/118 (0%)	0	1/118 (0.8%)	1
Constipation	0/118 (0%)	0	1/118 (0.8%)	1
Reproductive system and breast disorders
Pelvic Pain	0/118 (0%)	0	1/118 (0.8%)	1
Vascular disorders
Bleeding Anterior Venous Fistula	0/118 (0%)	0	1/118 (0.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.