Clinical trial NCT05443815: Registry on the Use of HaemoCER-Plus in the Treatment and Prevention of Post-resectional Bleeding
Official title: Prospective Multicenter Registry on the Use of HaemoCer-PLUSPlus in the Treatment and Prevention of Post-resectional Bleeding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post-resectional Bleeding
Lead sponsor: Istituto Clinico Humanitas Mater Domini
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number and proportion of bleeding events in patients receiving HaemoCer-PLUS
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Castellanza
country: Italy
facility: Humanitas-Mater Domini
Study officials:
References: