Using PuraStat® to reduce delayed bleeding after colorectal surgery
A Multicenter Randomized Controlled Trial to Evaluate the Efficacy of a Hemostatic Agent (PuraStat®) in Reducing Delayed Bleeding After Endoscopic Colorectal Submucosal Dissection
This study is testing if a new product called PuraStat® can help reduce delayed bleeding after colorectal surgery in patients who are at high risk for bleeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 288 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Société Française d'Endoscopie Digestive Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT05031325 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of PuraStat®, a hemostatic agent, in reducing the incidence of delayed bleeding following endoscopic submucosal dissection (ESD) for colorectal lesions. The study focuses on patients at high risk of bleeding, particularly those on anticoagulant or antiplatelet therapy. By comparing PuraStat® to standard treatment methods, the trial aims to determine if this new approach can improve patient outcomes and reduce complications associated with delayed bleeding. The study will also assess the side effects and overall effectiveness of both strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a single colorectal lesion requiring ESD and who are on anticoagulant or antiplatelet therapy.
Not a fit: Patients with severe fibrosis, a history of familial colorectal polyposis, or those who may have an allergic reaction to PuraStat® may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of delayed bleeding in patients undergoing colorectal surgery, improving recovery and outcomes.
How similar studies have performed: Previous studies have indicated that hemostatic agents like PuraStat® can reduce bleeding rates, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients of both sexes aged 18 years or older * Patient with a validated indication for colonoscopy for colorectal lesions * Patients with a single colorectal lesion to be resected by ESD according to European recommendations. * Patients with a colorectal neoplastic lesion (≥3 cm) * Patients taking anticoagulants (acetylsalicylic acid \>300 mg/day) or antiplatelet agents (clopidogrel, prasugrel, ticagrelor, clopidogrel) and managed according to European recommendations for ESD (including patients who may require heparin replacement) * Written consent signed after clear, fair, and understood information. * Patients with social security coverage. Exclusion Criteria: * Patients who may have an allergic reaction to the substances of PuraStat®. * Patients with severe fibrosis * Patients with a history of familial colorectal polyposis (familial adenomatous, Lynch syndrome, Peutz-Jeghers syndrome) * Patients with a score ASA greater than or equal to 4 or 5 * Patients with a platelet count of 50,000/mm3 * Patients with acquired (non-medicated) or inherited bleeding disorders * Patients who are being treated with acetylsalicylic acid but whose treatment is discontinued at the time of the procedure (therapeutic window) * Patients with advanced cancer or inflammatory bowel disease, including ulcerative colitis (with colonic involvement) * Contraindication to general anesthesia * Patients with a mental disorder, drug addiction, alcoholism, etc. * Pregnant women or women wishing to become pregnant during the study * Patients already participating or scheduled to participate in other clinical trials * Lesion that has been previously resected by mucosectomy * Patient with an initial metastatic lesion prior to colonoscopy. * Patient unable to give personal consent * Lack of signed informed consent
Where this trial is running
Lyon
- Hopital Edouard Herriot — Lyon, France (Recruiting)
Study contacts
- Study coordinator: Mathieu PIOCHE, Pr
- Email: mathieu.pioche@chu-lyon.fr
- Phone: + 33 4 72 11 03 43
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.