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Clinical trial

Usage of Tranexamic Acid During Colonic Endoscopic Resection Procedures for Reduction Intraprocedural and Postprocedural Bleeding

ID
Name
0017-22-ASF
Description
Colonoscopy with polypectomy reduces the incidence and mortality associated with colon cancer. However, polypectomy is associated with adverse events such as bleeding. Tranexamic acid (TXA) is a synthetic derivative of lysine that exerts antifibrinolytic effects and may prevent bleeding. The investigators aim to evaluate the effect of local TXA on preventing intraprocedural and postprocedural bleeding in patients undergoing endoscopic mucosal resection (EMR) of large colon polyps.
Trial arms
Trial start
2022-05-01
Estimated PCD
2024-04-01
Trial end
2024-10-01
Status
Recruiting
Phase
Early phase I
Treatment
Tranexamic acid
Submucosal injection of standard solution including TXA during EMR procedure
Arms:
Tranexamic Acid group
Other names:
TXA, Cyklokapron
Standard
Injection of standard solution
Arms:
Standard therapy group
Other names:
adrenaline, epinephrine
Size
200
Primary endpoint
Postprocedural bleeding
Within 2 weeks of procedure
Eligibility criteria
Inclusion Criteria: * Patients referred for endoscopic resection of non-neoplastic and neoplastic lesions in the colon presenting to our tertiary academic center. * Age \> 18 years Exclusion Criteria: * patients with histories of allergic reactions to TXA * history of seizures * pregnancy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-08-08

1 organization

2 products

1 indication

Organization
Assaf-Harofeh Medical Center
Product
Tranexamic acid
Indication
Colorectal Cancer
Product
Standard