PeproStat as a Topical Agent Used to Stop Bleeding in Patients Undergoing Surgery

NCT03131336 | Completed Phase 2

• 1 other identifier: HX-02-PEP
• Study Type: interventional
• Target: 169
• Locations: 5 countries
• Sites: 5

Brief Summary

The purpose of this study is to test the effectiveness and safety of a new peptide-based coagulant, PeproStat. The study drug will be applied to patients undergoing liver/soft tissue surgery, vascular surgery or spine surgery. The speed of action of the new coagulant, that is applied with a gelatin sponge, will be compared to the same sponge but with saline (a commonly used standard of care).

Conditions

Bleeding

Outcome Measures

Primary Outcomes (1)

• The difference in time to hemostasis in minutes when using verum vs placebo

  Efficacy in terms of Time to hemostasis, mean (mTTH) at the primary target bleed site (TBS),measured in minutes from the start of treatment application (TxStart) at the TBS to the achievement of haemostasis at that site or to the end of the 10-minute assessment period if haemostasis has not yet been achieved.

  10 minutes after application

Secondary Outcomes (28)

• Percentage of subjects achieving hemostasis at 1 min haemostasis in adult subjects undergoing open liver/soft tissue, vascular and spine surgery using descriptive statistics

  1 minute after start of treatment

• Percentage of subjects achieving hemostasis at 2 min haemostasis in adult subjects undergoing open liver/soft tissue, vascular and spine surgery using descriptive statistics

  2 minutes after start of treatment

• Percentage of subjects achieving hemostasis at 3 min haemostasis in adult subjects undergoing open liver/soft tissue, vascular and spine surgery using descriptive statistics

  3 minutes after start of treatment

• Percentage of subjects achieving hemostasis at 5 min haemostasis in adult subjects undergoing open liver/soft tissue, vascular and spine surgery using descriptive statistics

  5 minutes after start of treatment

• Percentage of subjects achieving hemostasis at 7 min haemostasis in adult subjects undergoing open liver/soft tissue, vascular and spine surgery using descriptive statistics

  7 minutes after start of treatment

Study Arms (2)

PeproStat

EXPERIMENTAL

PeproStat 2.5mg/mL soaked into haemostatic gelatin sponge, applied to a target bleeding site

Drug: PeproStat

Saline

PLACEBO COMPARATOR

Saline soaked into haemostatic gelatin sponge, applied to a target bleeding site

Drug: Saline

Interventions

PeproStat DRUG

solution for local application

Also known as: PeproStat 2.5 mg/mL, soaked into Spongostan

PeproStat

Saline DRUG

solution for local application

Also known as: Absorbable gelatin sponge (Spongostan) soaked with saline

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is undergoing a planned open liver/soft tissue surgery, vascular surgery or spine surgery.
• Subjects are able and willing to provide written informed consent to participate in this study.
• Adult males and females ≥18 years of age at screening.
• Willing and able to comply with all protocol requirements including follow-up assessments.
• Male subjects must be willing and able to use adequate contraception from enrollment through to the 30 day follow-up visit.
• Women of childbearing potential (WCBP)C have to use highly effective methods of contraception from enrollment through to the 30 day follow-up visit.
• Intraoperative:
• The subject presents an identified target bleeding site with mild or moderate bleeding, which conventional surgical techniques are insufficient to control or are inappropriate and would otherwise be a candidate for standard haemostats.
• The subject presents no intraoperative complications, other than bleeding, that may interfere with study assessments as judged by the Investigator.
• The subject presents no contaminated areas of the body, signs of infection or abscess development.
• Total target bleeding site surface area of ≤ 70 cm2, defined within one or two TBSs.

You may not qualify if:

• Subject is undergoing emergency surgical procedure.
• Use of study treatment and sponge in
• Closure of skin incisions as the sponge may interfere with the healing of skin edges.
• Intravascular compartments because of the risk of embolization following sponge application.
• Recipient of an organ transplant.
• Haematologic, biochemistry and coagulation panel thresholds at screening:
• Haemoglobin ≤ 9.0 g/dL.
• Platelet count ≤100,000/mm3 (≤ 100 x 109/L).
• International Normalized Ratio (INR) \> 2.0 or activated Partial Thromboplastin Time (aPTT) ratio \> 2.0.
• Fibrinogen level \< 1.5 g/L.
• Aspartate Aminotransferase (AST) or Alanine aminotransferase (ALT) ≥ 3 times the upper limit normal range, except for subjects undergoing liver resection surgery where there is no upper limit for these analytes due to the nature of their disease.
• Severe renal failure.
• Any other disease or condition that may affect normal blood clotting, for example thrombocytopenia, as judged by the Investigator.
• A known history of anaphylaxis or allergic reaction to human albumin, PEGylated proteins, yeast or moulds, porcine products or other components in the study medication or sponge.
• Participation in another investigational drug or device research study within 30 days before and after enrolment in the current study.

Sponsors & Collaborators

• Haemostatix Ltd: lead

Study Sites (5)

University Clinical Hospital, Bolnicka 25

Sarajevo, 71000, Bosnia and Herzegovina

Location

University Clinical Hospital Centre "Sestre Milosrdnice", Vinogradska cesta 29

Zagreb, 10000, Croatia

Location

Klinika Neurochirurgii Gdanskie Centrum Kliniczne, ul. Dębinki 7

Gdansk, 80-952, Poland

Location

Clinical centre of Serbia, Clinic for vascular and endovascular surgery, Koste Todorovica Street 8

Belgrade, 11000, Serbia

Location

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Sodium Chloride; Gelatin Sponge, Absorbable; Fibrin Foam

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Surgical Sponges; Surgical Equipment; Equipment and Supplies; Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Paul Hayes

  Addenbrookes NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, interventional, randomized, controlled, double-blind, parallel group

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 27, 2017
• Study Start: March 31, 2017
• Primary Completion: August 23, 2017
• Study Completion: October 11, 2017
• Last Updated: February 27, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); BO (1); SE (1); GB (1); CR (1)