Clinical trial NCT03983707: A Evaluation of the Utilisation, Effectiveness and Safety of Purastat® in the Management of Gastrointestinal Bleeding
Official title: A Multicentre Prospective Observational Study to Evaluate the Utilisation, Effectiveness and Safety of Purastat® in the Management of Gastrointestinal Bleeding
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Bleeding
Delayed Bleeding
Keywords: Purastat
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: 3-D Matrix Europe SAS
name: Gloucestershire Hospitals NHS Foundation Trust
name: Cambridge University Hospitals NHS Foundation Trust
name: University Hospital Birmingham NHS Foundation Trust
name: Nottingham University Hospitals NHS Trust
name: Mid and South Essex NHS Foundation Trust
name: East Kent Hospitals University NHS Foundation Trust
name: University College London Hospitals
name: North Tees and Hartlepool NHS Foundation Trust
name: Brighton and Sussex University Hospitals NHS Trust
name: King's College Hospital NHS Trust
name: Imperial College Healthcare NHS Trust
name: Heart of England NHS Foundation Trust
name: The Leeds Teaching Hospitals NHS Trust
name: Barts & The London NHS Trust
name: London North West Healthcare NHS Trust
name: Manchester University NHS Foundation Trust
name: Oxford University Hospitals NHS Trust
name: Glasgow Royal Infirmary
name: Guy's and St Thomas' NHS Foundation Trust
name: Northern Care Alliance NHS Foundation Trust
name: University Hospital Southampton NHS Foundation Trust
First posted: 2019-06-12
Enrollment: 379
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with GI bleeding or a high risk of bleeding during endoscopic procedures where Purastat® is used

Brief summary: Problem statement

GI bleeding can arise from peptic ulcers, malignancy, angiodysplasia or during endoscopic resection procedures such as endoscopic mucosal resection and endoscopic submucosal dissection. This is conventionally treated using heat therapy or clips. These methods carry a risk of thermal injury or perforation. Purastat® is a novel synthetic haemostatic agent licensed as a CE marked device for use in GI bleeding. It also has the potential to enhance endoscopic mucosal wound healing and may play a role in preventing delayed bleeding. However, clinical data on its effectiveness in the GI tract is limited. Prospective data collection on the range of indications for Purastat® use and outcome data related to clinical effectiveness, safety and feasibility is required to inform clinicians about the best use for this agent.

Research question / hypothesis

To establish a prospective registry study to collect outcome data related to the use of Purastat® for the clinical management of GI bleeding or prevention of bleeding

Study Design

Prospective multicentre cohort study

Study Participants

Adults with GI bleeding or a high risk of bleeding during endoscopic procedures where Purastat® has been used

Follow-up duration

All patients will be followed up as per standard clinical care where applicable

Planned Study Period

2 years

Primary Objective

To assess the effectiveness of Purastat® as a haemostatic agent when used in the treatment of GI bleeding

Secondary Objectives

To assess the incidence of delayed bleeding after use of Purastat®, defined as procedure related bleeding up to 28 days following endoscopic resection To evaluate the rate of rebleeding following primary application of Purastat® for haemostasis To assess the technical feasibility and ease of use of Purastat® when used in the treatment or prevention of GI bleeding To monitor any unexpected reactions that may be attributed to the use of Purastat® To describe utilisation patterns in different clinical centres (indication, patient characteristics etc) and to observe trends in utilisation over time

Detailed description: Problem statement

GI bleeding can arise from peptic ulcers, malignancy, angiodysplasia or during endoscopic resection procedures such as endoscopic mucosal resection and endoscopic submucosal dissection. This is conventionally treated using heat therapy or clips. These methods carry a risk of thermal injury or perforation. Purastat® is a novel synthetic haemostatic agent licensed as a CE marked device for use in GI bleeding. It also has the potential to enhance endoscopic mucosal wound healing and may play a role in preventing delayed bleeding. However, clinical data on its effectiveness in the GI tract is limited. Prospective data collection on the range of indications for Purastat® use and outcome data related to clinical effectiveness, safety and feasibility is required to inform clinicians about the best use for this agent.

Research question / hypothesis

To establish a prospective registry study to collect outcome data related to the use of Purastat® for the clinical management of GI bleeding or prevention of bleeding

Study Design

Prospective multicentre cohort study

Study Participants

Adults with GI bleeding or a high risk of bleeding during endoscopic procedures where Purastat® has been used

Follow-up duration

All patients will be followed up as per standard clinical care where applicable

Planned Study Period

2 years

Primary Objective

To assess the effectiveness of Purastat® as a haemostatic agent when used in the treatment of GI bleeding

Secondary Objectives

To assess the incidence of delayed bleeding after use of Purastat®, defined as procedure related bleeding up to 28 days following endoscopic resection To evaluate the rate of rebleeding following primary application of Purastat® for haemostasis To assess the technical feasibility and ease of use of Purastat® when used in the treatment or prevention of GI bleeding To monitor any unexpected reactions that may be attributed to the use of Purastat® To describe utilisation patterns in different clinical centres (indication, patient characteristics etc) and to observe trends in utilisation over time

Eligibility criteria: Inclusion Criteria:

* Active GI bleeding or high risk for active GI bleeding

Exclusion Criteria:

* Variceal or arterial bleeding

Primary outcomes:
measure: Effectiveness of Purastat® in controlling bleeding
timeFrame: Day 1 (intraprocedural bleeding)
measure: Effectiveness of Purastat® in controlling bleeding
timeFrame: Day 28 (delayed bleeding)
Secondary outcomes:
measure: Effectiveness of Purastat® in preventing delayed bleeding
timeFrame: Day 28
measure: Technical feasibility of use of Purastat®
timeFrame: Day 1 (periprocedural)
measure: Unexpected reactions that may be attributed to the use of Purastat®
timeFrame: Day 28
measure: Patterns of Purastat® usage
timeFrame: 24 months
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
state: Hampshire
Study officials:
affiliation: Portsmouth Hospitals NHS Trust
name: Pradeep Bhandari
role: PRINCIPAL_INVESTIGATOR
References: