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

• Conditions: Post-resectional Bleeding
• Interventions: Device: HaemoCer-PLUS

• Registration Number: NCT05443815
• Lead Sponsor: Istituto Clinico Humanitas Mater Domini

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-06-29
• Status Verified: 2022-07
• Study Start: 2022-07-01
• Primary Completion: 2022-07-01
• Study First Posted: 2022-07-05
• Last Update Submitted: 2022-07-05
• Last Update Posted: 2022-07-08
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HaemoCer-PLUS	HaemoCer-PLUS	Patients who had receive HaemoCer-PLUS

Primary Outcome Measures

Name	Time	Method
Number and proportion of bleeding events in patients receiving HaemoCer-PLUS	6 months	Number and proportion of bleeding events controlled by application of HaemoCer

Trial Locations

Locations (1)

Humanitas-Mater Domini; 🇮🇹 Castellanza, Italy