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Completed

NCT Number: NCT03654560

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

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.

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Key information

Conditions

Hemostasis Bleeding Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Raymond Schaerf

Burbank, California, 91505, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  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.

    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.

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

United Health Products, Inc.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 31, 2018
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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