HemostasisNCT03654560

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

A study testing HemoStyp and Surgicel in people with Hemostasis and Bleeding, run by United Health Products, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 2 years and older
Conditions the study is for: Hemostasis, Bleeding
What is being tested?: HemoStyp and Surgicel
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 236 participants
Where: 1 siteUnited States
Study dates: 28 Dec 2018to 12 Sep 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Elective procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery);
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;
Ages: Pediatric subjects 2 years to 17 years of age and adult subjects 18 years of age or older; and
Subjects or parent or legal guardian of the subject who are willing and able to sign consent.

Who cannot join

Physical or psychological condition which would impair study participation;
Indications for emergency surgery;
Pre-operative laboratory findings of a hematologic disorder;
Subjects with history of moderate to severe allergies;
Subjects undergoing minimally invasive laparoscopic surgery;
Subjects who will require platelet or fresh frozen plasma transfusion during surgery;
Subjects who are pregnant or breast-feeding at the time of surgery; or
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Raymond Schaerf
Burbank, California, 91505

Other trials in United States

About this study

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.

Read the 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.

Conditions: Hemostasis, Bleeding
Being tested: HemoStyp, Surgicel
Medical subject headings: Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HemoStypDevice
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.
SurgicelDevice
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.

Study groups in NCT03654560
Study group	Role	What they receive
HemoStyp	Active comparator	Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use. Receives: Device: HemoStyp
Surgicel	Active comparator	Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use. Receives: Device: Surgicel

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 10 minutes

Secondary outcomes (4)

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.
Measured: Between 2 minutes and 10 minutes
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.
Measured: 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
Measured: 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.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Dec 201812 Sep 2019

First posted31 Aug 2018
Study start28 Dec 2018
Primary completion5 Aug 2019
Study completion12 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HemostasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 236 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03654560
Sponsor's protocol ID: UHP001
Status last verified: Oct 2019
First submitted: 27 Aug 2018
Last updated: 22 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hemostasis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting
ClinicalTrials.gov ID: NCT03654560
Acronym / sponsor ID: UHP001
Conditions: Hemostasis, Bleeding
Study type: Interventional
Recruitment status: Completed
Enrolment: 236 participants (actual)
Lead sponsor: United Health Products, Inc.Industry (pharma, biotech, devices)
Study start: 28 Dec 2018 (actual)
Primary completion: 5 Aug 2019 (actual)
Study completion: 12 Sep 2019 (actual)
First posted: 31 Aug 2018 (actual)
Results: Posted 22 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
HemoStyp	Active comparator	Device: HemoStypSubjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.
Surgicel	Active comparator	Device: SurgicelSubjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Elective procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery);
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;
Ages: Pediatric subjects 2 years to 17 years of age and adult subjects 18 years of age or older; and
Subjects or parent or legal guardian of the subject who are willing and able to sign consent.

Key exclusion criteria (8 listed)

Physical or psychological condition which would impair study participation;
Indications for emergency surgery;
Pre-operative laboratory findings of a hematologic disorder;
Subjects with history of moderate to severe allergies;
Subjects undergoing minimally invasive laparoscopic surgery;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HemoStypDuring 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.	Device	HemoStyp
SurgicelDuring 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.	Device	Surgicel

Primary outcome

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.
Time frame: 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.

4 secondary outcomes

Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes
Time frame: Between 2 minutes and 10 minutes
Rate of Subjects Achieving Intraoperative Hemostasis at the Target Bleeding Site
Time frame: Intraoperative period
Rate of Subjects With Intraoperative Re-bleeding From the Target Bleeding Site
Time frame: 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
Time frame: 30 days

Results and safety

Results posted to the registry on 22 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HemoStyp	118	114
Surgicel	118	117

Primary outcome: 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.

Time frame: 10 minutes. Median (95% Confidence Interval). Unit: seconds

Measure	HemoStyp n = 118	Surgicel n = 118
Value	36 (31 to 47)	67 (57 to 89)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From treatment to 30 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HemoStyp	1 of 118 (0.8%)	0 of 118 (0%)	3 of 118
Surgicel	0 of 118 (0%)	4 of 118 (3.4%)	1 of 118

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hemostasis

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Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
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Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
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Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HemoStyp and Surgicel in people with Hemostasis and Bleeding, run by United Health Products, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03654560.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.