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

FASTOP study

22

Characteristics of patients* evaluated for efficacy and safety of PuraStat (N=22) (%) Age median [IQR] 70.5 (65.3-76.5) Sex Female 9 (41%) Male 13 (59%) PS 0 22 (100%) 1 0 (0%) Smoking Never 10 (45%) Ever 12 (55%) diagnosis primary lung cancer 21 (95%) metastatic lung cancer 1 (5%) operation lobectomy 17 (77%) bi-lobectomy 0 (0%) segmentectomy 5 (23%) others 0 (0%) retractor not used 9 (41%) used 13 (59%) comorbidities absent 3 (14%) present 9 (86%) anticoagulants not used 18 (82%) used, suspended 2 (9%) used, continued 2 (9%) all cases continued the aspirin IQR, interquartile range

Between September 2023 and April 2024, 64 patients were enrolled, all of whom underwent surgery. Of these, eighty PAs of 56 patients were resected with an automatic suturing device, and the degree of exudative haemorrhage at the proximal stump was scored using the bleeding score. Compression haemostasis was performed for 30 s on 31 PAs from 28 patients with a bleeding score >-1. Purastat was applied as the study treatment in 23 PAs of 22 patients with persistent exudative haemorrhage. One patient violated the protocol by applying an agent to one PA stump using an attachment that was not specified in the protocol.

No patient experienced rebleeding, and the rate of postoperative rebleeding was 0%. At least one adverse event was reported in all 22 patients treated with Purastat. Specifically, no grade 4 or 5 adverse events were reported. Only two adverse events were attributed to Purastat use: grade 1 eosinophilia in one patient and grade 1 pleural effusion in another. No Purastat use-related intraoperative complications or adverse events were observed between postoperative days 31 and 90.

The rate of additional haemostatic treatment required was 4.35% (95% confidence interval, 0-19.0%), which was within the prespecified threshold of 25%. The rate of additional intraoperative haemostasis required was 13.0%. Additional intraoperative haemostasis performed in all three patients involved the use of fibrin sealant patches. The median time to achieve haemostasis and that required to prepare Purastat was 30.0 s (range, 10-224) and 95 s (range, 22-168). The median amount of PuraStat used was 3.0 ml. No patient experienced rebleeding, and the rate of postoperative rebleeding was 0%. The median amount of intraoperative haemorrhage was 0ml. The median amount of total drainage volume was 340ml. The median drainage period was 2 days. The media postoperative hospitalization period was 7 days.

Our study adequately suggested that Purastat, a novel synthetic haemostat, is effective and safe for exudative haemorrhage at the proximal PA stump dissected using an automatic suturing device.

Dec. 01, 2025

Nov. 14, 2025

https://link.springer.com/article/10.1007/s00595-025-03168-x

Yes

We will consider IPD sharing if required during the publication process

https://jrct.mhlw.go.jp/latest-detail/jRCTs042230072

Ode Yasuhisa

Shizuoka Cancer Center

1007Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka

y.ode@scchr.jp

Katsumata Shinya

Shizuoka Cancer Center

1007Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka

+81-55-989-5222

shi.katsumata@scchr.jp

Complete

Sept. 01, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(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

(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

Both

Exudative hemorrhage after stapling of pulmonary artery during thoracic surgery

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

Rate of additional hemostatic treatment required

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

+81-55-989-5222

July. 31, 2023

none