The safety and efficacy of Fibrin sealant Thai Red Cross Society compared with commercially Fibrin sealant in neurosurgery

Phase II/III open-label randomized-controlled trial to evaluate the safety and efficacy of Fibrin sealant Thai Red Cross Society compared with commercially available fibrin sealant (TISSEEL) in neurosurgery

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20251005003

Enrollment

Registered

2025-10-05

Start date

2025-11-04

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Transsphenoidal surgery, Cranial surgery involving paranasal sinus opening, Intradural spinal tumor surgery and Spinal surgery with incidental dural tear that neurosurgeon decide to use fibrin sealant for preventing CSF leakage. Transsphenoidal surgery, Cranial surgery involving paranasal sinus opening, Intradural spinal tumor surgery, Spinal surgery with incidental dural tear, Fibrin Sealant

Interventions

IP name : Fibrin sealant TRCS Drug substance : 1. Sealer protein solution: Human fibrinogen 60 mg/ML 2. Thrombin solution: Human thrombin 500 IU/ML Pharmaceutical form : Solution Appearance: Colo

Experimental Drug,Active Comparator Drug

fibrin sealant from Thai Red Cross Society,Tisseel

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 18 years old and older 2. Patients provide informed consent to participate in the study 3. One of the following: 3.1 Patients undergoing transsphenoidal surgery 3.2 Operations that expose air sinus in neurosurgical procedures and surgeons determine using a surgical sealant 3.3 All patients diagnosed with an intradural spinal tumor 3.4 Spinal surgery with incidental dural tear and surgeons determine using a surgical sealant

Exclusion criteria

Exclusion criteria: 1. Diagnosed with active infections such as meningitis, brain abscesses,spondylodiscitis, and spinal epidural abscess 2. Underlying with bleeding tendency 3. Patients who are unable to have long-term follow-up 4. Pre-existing positive serologic test (HBsAg, anti-HCV, anti-HIV or anti-TP)

Design outcomes

Primary

Measure	Time frame
CSF leakage post-operative 3 months Rate of CSF leakage by evaluating clinical CSF rhinorrhea or pseudomeningocele	—

Secondary

Measure	Time frame
Intraoperative CSF leakage end of the operation CSF leakage grading ,Clinical CSF leakage post-operative 1 week and 1 month Clinical assessment,Sealant-related complications including infection and bleeding post-operative 1 month Clinical assessment,pseudomeningocele post-operative 3 months imaging by CT or MRI	—

Countries

Thailand

Contacts

Public ContactKusawadee Juengsirakulwit

Faculty of Medicine, Chulalongkorn University

kjuengsirakulwit@gmail.com0817315755

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026