Treatment Of Gastrointestinal Bleeding With PuraStat® - Prospective Multicenter-Pilotstudy For The Use of Purastat® for GI-Bleeding

Phase 4

Recruiting

• Conditions: K21.0; K58.8; K63.3; K92.2; Gastro-oesophageal reflux disease with oesophagitis; Other and unspecified irritable bowel syndrome; Ulcer of intestine; Gastrointestinal haemorrhage, unspecified

• Registration Number: DRKS00012480
• Lead Sponsor: Charité Campus Benjamin Franklin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-13
• Results First Posted: 2021-06-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

Inclusion criteria were:
All gastrointestinal bleedings between Forrest Ib-IIc and lower, large-area bleedings, diffuse bleedings.
Subgroup for Forrest Ia bleeding (decision of the treating physician), signed consent of the patients if possible, patients between 18-80 years

Exclusion Criteria

Forrest IA-bleedings should be treated conventionally. If the physician recognized an indication for the use of PuraStat® in Forrest IA-bleeding these patients were analyzed as a subgroup

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Achievement of a sufficient bleeding stop by PuraStat®

Secondary Outcome Measures

Name	Time	Method
Reduction of the re-bleeding rate, documentation of the risk profile and complication rate of PuraStat®