FASTOP study

JRCT ID: jRCTs042230072

Registered date:01/09/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Exudative hemorrhage after stapling of pulmonary artery during thoracic surgery
• Date of first enrollment: 14/09/2023
• Target sample size: 21
• Study type: Interventional
• Intervention(s): Using PuraStat for exudative hemorrhage after stapling of pulmonary artery during thoracic surgery

Outcome(s)

• Primary Outcome: Rate of additional hemostatic treatment required

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Ode Yasuhisa
• Source(s) of Monetary Support: 3-D Matrix, Ltd.