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

Prospective Multicenter Registry on the Use of HaemoCer-PLUSPlus in the Treatment and Prevention of Post-resectional Bleeding

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post-resectional Bleeding
• Intervention / Treatment: Device: HaemoCer-PLUS

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Benedetto Mangiavillano, MD; Phone Number: 00390331476381; Email: benedetto.mangiavillano@materdomini.it

Study Locations

• Italy
  • Castellanza, Italy, 21053
    • Humanitas-Mater Domini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HaemoCer-PLUS; Patients who had receive HaemoCer-PLUS	Device: HaemoCer-PLUS; HaemoCer-PLUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and proportion of bleeding events in patients receiving HaemoCer-PLUS	Number and proportion of bleeding events controlled by application of HaemoCer	6 months

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas Mater Domini

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 30, 2023

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No