NCT03654560

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

Completed NA Results posted Last updated 22 October 2020

What this trial tests

NA trial testing HemoStyp in Hemostasis in 236 participants. Completed in 12 September 2019.

Timeline

28 December 2018

Primary endpoint
5 August 2019

12 September 2019

Quick facts

Lead sponsor	United Health Products, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	236
Start date	28 December 2018
Primary completion	5 August 2019
Estimated completion	12 September 2019
Sites	1 location across United States

Drugs / interventions tested

• HemoStyp
• Surgicel

Conditions studied

• Hemostasis — all drugs for Hemostasis →
• Bleeding — all drugs for Bleeding →

Sponsor

United Health Products, Inc.

Who can join

2 and older, any sex, with Hemostasis or Bleeding. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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. Primary · 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 las

Group	Value	95% CI
HemoStyp	36	31 – 47
Surgicel	67	57 – 89

Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes Secondary · 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 minutes

Group	Value	95% CI
HemoStyp	118
Surgicel	96

5 minutes

Group	Value	95% CI
HemoStyp	118
Surgicel	110

10 minutes

Group	Value	95% CI
HemoStyp	118
Surgicel	112

Rate of Subjects Achieving Intraoperative Hemostasis at the Target Bleeding Site Secondary · 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.

Group	Value	95% CI
HemoStyp	118
Surgicel	112

Rate of Subjects With Intraoperative Re-bleeding From the Target Bleeding Site Secondary · Intraoperative period post hemostasis

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

Group	Value	95% CI
HemoStyp	0
Surgicel	0

Rate of Subjects Requiring Surgical Re-exploration up to 30 Days After Surgery for Re-bleeding From the Target Bleeding Site Secondary · 30 days

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

Group	Value	95% CI
HemoStyp	0
Surgicel	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From treatment to 30 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

HemoStyp

Serious: 1/118 (1%)

Deaths: 3/118

Surgicel

Serious: 0/118 (0%)

Deaths: 1/118

Serious adverse events (2 terms)

Reaction	System	HemoStyp	Surgicel
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—
Soft Tissue infection	Skin and subcutaneous tissue disorders	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	HemoStyp	Surgicel
Abdominal Pain	Gastrointestinal disorders	—	—
Pelvic Pain	Reproductive system and breast disorders	—	—
Bleeding Anterior Venous Fistula	Vascular disorders	—	—
Seroma	Blood and lymphatic system disorders	—	—
Constipation	Gastrointestinal disorders	—	—

Most-reported serious reactions: Pneumonia, Soft Tissue infection.

Data from ClinicalTrials.gov NCT03654560 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Drugs to reduce bleeding and transfusion in major open vascular or endovascular surgery: a systematic review and network meta-analysis.
   Beverly A, Ong G, Kimber C, Sandercock J, et al · · 2023 · cited 12× · PMID 36800489 · DOI 10.1002/14651858.cd013649.pub2