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FASTOP study

Feasibility and safety study of PuraStat (a novel self-assembling peptide) for exudative hemorrhage after stapling of pulmonary artery during thoracic surgery

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042230072
Enrollment
21
Registered
2023-09-01
Start date
2023-09-14
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Exudative hemorrhage after stapling of pulmonary artery during thoracic surgery

Interventions

Using PuraStat for exudative hemorrhage after stapling of pulmonary artery during thoracic surgery

Sponsors

Ode Yasuhisa
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Age 18 years or older (2) ECOG performance status (PS) is 0 or 1 (3) Planned surgery is scheduled within 2 weeks (4) Patient is scheduled for an anatomical lung resection (segmentectomy, lobectomy, bilobectomy, pneumonectomy or a combination of these surgical procedures) (5) Major organ function is preserved (6) Written informed consent has been obtained

Exclusion criteria

Exclusion criteria: (1) Patients with a history of coagulation disorder (2) Patients with psychiatric disorders that make it difficult to include in the study (3) Patients receiving continuous systemic administration of steroids or immunosuppressants (4) Patients with a history of hypersensitivity to peptide or protein products (5) Patients with a history of serious hypersensitivity

Design outcomes

Primary

MeasureTime frame
Rate of additional hemostatic treatment required

Secondary

MeasureTime frame
Time to achieve hemostasis Rate of additional intraoperative hemostatic treatments required Time required to prepare PuraStat Amount of PuraStat used Duration of chest drainage Drain discharge volume Length of postoperative hospital stay Intraoperative complications Adverse events within 30 days after surgery Rate of postoperative rebleeding

Contacts

Public ContactShinya Katsumata

Shizuoka Cancer Center

shi.katsumata@scchr.jp+81-55-989-5222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026