Registry on the Use of HaemoCER-Plus in the Treatment and Prevention of Post-resectional Bleeding

NCT05443815 | Unknown DMC

• 1 other identifier: 11
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Gastrointestinal bleeding is defined as clinical evidence of bleeding manifested by melena, hematochezia that required endoscopic hemostasis. GI bleeding associated to endoscopic procedure is defined as clinical evidence of bleeding and a drop in hemoglobin of ≥ 2g/dL on the day of the procedure (early bleeding) or up to 14 days after the procedure (delayed bleeding).GI bleeding is, nevertheless, a common complication of endoscopic procedures, such as endoscopic mucosal resection (EMR) and endoscopic sub mucosal dissection (ESD). For example, colorectal ESD, which is technically more difficult than gastric or esophageal ESD because of the anatomical features of the colon, present an increased risk of delayed bleeding. According to literature, early bleeding occurs on average in 5,3% of endoscopic resections of the whole digestive tract, with bleeding rates per location as follows: esophagus 9.4%, stomach 9.1%, duodenum 3.6%, colon 3.4%. Concerning delayed bleeding, it is assessed to complicate 3.1% of endoscopic resection procedures. The bleeding rate in the duodenum is usually the highest (6.3%), followed by colon at (3.6%), stomach (1.5%) and esophagus (0.9%). Age, lesion size and piecemeal resection are associated with an increased risk of bleeding. Usage of aspirin or NSAIDs seems to not increase risk of post-polypectomy bleeding, while clopidogrel and warfarin do and should be discontinued in the periprocedural period to prevent the occurrence of post-polypectomy bleeding. Direct oral anticoagulants (DOAC) administration shows similar post-procedural gastrointestinal bleeding risk to anti-vitamin K antagonists (VKA) administration in patients undergoing endoscopic procedures.

Conditions

Post-resectional Bleeding

Outcome Measures

Primary Outcomes (1)

• Number and proportion of bleeding events in patients receiving HaemoCer-PLUS

  Number and proportion of bleeding events controlled by application of HaemoCer

  6 months

Study Arms (1)

HaemoCer-PLUS

Patients who had receive HaemoCer-PLUS

Device: HaemoCer-PLUS

Interventions

HaemoCer-PLUS DEVICE

HaemoCer-PLUS

HaemoCer-PLUS

Eligibility Criteria

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

Study Population

This will be a multicenter and observational registry of patients treated with HaemoCer- PLUS to obtain hemostasis. All centres participating in the project will select the patients according to the in- and exclusion criteria. Ethical approval will be obtained in every participant hospital. All patients entering this new registry will have to sign a patient inform consent.

You may qualify if:

• patients who had authorized to use and process their personal details for the purpose of research;
• patients able to express their consent;
• age \>18 years;
• endoscopic procedures where HaemoCer-PLUS has been used for hemostasis or prevention of bleeding

You may not qualify if:

• hemostatic therapies other than HaemoCer-PLUS
• Known coagulopathy likely to affect risk of bleeding.

Sponsors & Collaborators

• Istituto Clinico Humanitas Mater Domini: lead

Study Sites (1)

Humanitas-Mater Domini

Castellanza, 21053, Italy

Location

Central Study Contacts

Benedetto Mangiavillano, MD

CONTACT

00390331476381; benedetto.mangiavillano@materdomini.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 30, 2023
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)