Prospective, multicenter randomized controlled trial of the self-assembling hemostatic gel PuraStat to prevent delayed bleeding after endoscopic resections

Prospective, multicenter randomized controlled trial of the self-assembling hemostatic gel PuraStat to prevent delayed bleeding after endoscopic resections - PURPLE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00028119

Enrollment

248

Registered

2022-03-30

Start date

2022-05-30

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K63.5 K31.7

Interventions

Group 1: Endoscopic resection via hot snare plus application of PuraStat Group 2: Endoscopic resection via hot snare

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age = 18 years - Large (= 10mm in the duodenum or = 20mm in the colorectum) non-peduncled polyps deemed endoscopically resectable. Patients with more than one lesion can be included as long as the cumulative diameter of all resected lesions is no more than 100mm in the colorectum or 50mm in the duodenum. All lesions in the intervention group larger than 5mm must also be treated with PuraStat. - Planned hot snare resection of the polyps (en bloc or piecemeal) - Able and willing to give informed consent

Exclusion criteria

Exclusion criteria: - Planed Cold snare resection of the polyp - Significantly impaired coagulation (Quick 50 sec., Platelet count < 50 /nl) - Dual antiplatelet therapy - Single antiplatelet therapy combined with plasmatic anticoagulant agents (Heparin, Direct oral Anticoagulants, Vitamin K Antagonists, etc.) - Pregnancy

Design outcomes

Primary

Measure	Time frame
Clinically relevant delayed bleeding (CRDB) within 30 days after endoscopic resection.	—

Secondary

Measure	Time frame
Individual components of the primary endpoint: o CRDB-related transfusion of blood products o CRDB-related unplanned endoscopy o CRDB-related prolongation of hospital stay o CRDB-related re-admission to hospital care. · Other complications within 30 days after endoscopic resection (abdominal pain, fever, perforation) · Degree of wound healing of the mucosal defect and scarring of the initial resection site at followup endoscopy* · Recurrence of resected lesions at follow-up endoscopy* * (scheduled 8 – 10 weeks after resection in keeping with current guideline recommendations)	—

Measure

Time frame

Individual components of the primary endpoint: o CRDB-related transfusion of blood products o CRDB-related unplanned endoscopy o CRDB-related prolongation of hospital stay o CRDB-related re-admission to hospital care. · Other complications within 30 days after endoscopic resection (abdominal pain, fever, perforation) · Degree of wound healing of the mucosal defect and scarring of the initial resection site at followup endoscopy* · Recurrence of resected lesions at follow-up endoscopy* * (scheduled 8 – 10 weeks after resection in keeping with current guideline recommendations)

—

Countries

Germany

Contacts

Public ContactThomas von Hahn

Asklepios Klinik Barmbek

t.hahn@asklepios.com+49 (040) 181882-3810

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026