To investigate the performance and safety of SeraSeal to stop bleeding in patients

Phase 4

• Conditions: Health Condition 1: D699- Hemorrhagic condition, unspecified

• Registration Number: CTRI/2023/12/060763
• Lead Sponsor: Swast Kare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Written informed consent obtained

2.Men and women, adults, and pediatrics aged newborn or older.

3.Able and willing to comply with the procedures required by the protocol.

4.The subject must complete all screening/ preoperative evaluations.

5.The subjects must present an intra-operative bleeding site which has not been previously treated with any standard surgical method to control bleeding.

6.The subject on antithrombotic therapy (warfarin, heparin, aspirin, clopidogrel). (Acceptable clotting time for patients on Warfarin; PT <18.0 seconds (Normal 10-12 seconds) and Heparin: PTT <55.0 seconds (22-35 seconds).

7.Participants must be able to participate for 72hr duration of the study.

Exclusion Criteria

1.The presence of the hemostatic (cautery, staple gun, suture, hemostat) will not be allowed at the primary site for the duration of the primary endpoint evaluation period of the investigational product.

2.Any clinically infected wound, draining pus, surrounding erythema or edema, or patients with systemic signs of infections.

3. The subject on antibiotic therapy prior to enrollment.

4. The subject known to be pregnant or lactating.

5. The subject is currently participating in another clinical study and has received an investigational product or device within 30 days prior to study entry.

6. The subject is scheduled to undergo any surgical procedure other than the surgery which the subject is being treated under this protocol within 14 days prior to treatment.

7. Subjects with complicated diseased conditions.

8. Active hepatic disease (persistent alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels greater than 2.5 times the upper limit of normal).

9. The subject has an anticipated life expectancy of  < 6 months.

10.Inability to return for 30-days follow-up visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified