Clinical trial · Interventional
A Study of Fibrocaps™ in Surgical Bleeding
A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis. The investigational products were used in participants with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mild or Moderate Surgical Bleeding | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fibrocaps | Biological | — | UNRESOLVED |
| Gelatin sponge | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fibrocaps + Gelatin Sponge
- description
- Single application of Fibrocaps plus gelatin sponge.
- interventionNames
- Biological: Fibrocaps
- Biological: Gelatin sponge
- type
- ACTIVE_COMPARATOR
- label
- Gelatin Sponge
- description
- Single application of gelatin sponge alone.
- interventionNames
- Biological: Gelatin sponge
Primary outcomes (4)
- measure
- Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery
- timeFrame
- Within 5 minutes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Has signed an institutional review board/independent ethics committee (IRB/IEC)-approved informed consent document 2. Is undergoing one of the 4 surgical procedures described 3. Is at least 18 years old at time of consent 4. If female and of child-bearing potential, has negative pregnancy test during screening and is not breast-feeding 5. If able to reproduce, agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits when engaging in heterosexual intercourse 6. Has not received blood transfusion between screening and study treatment 7. Has mild to moderate surgical bleeding 8. Does not have intra-operative complications 9. Has not used a topical hemostat containing thrombin prior to study treatment 10. Has an approximate bleeding site surface area of less than or equal to 100 cm\^2 Exclusion Criteria: 1. Has known antibodies or hypersensitivity to thrombin or other coagulation factors 2. Has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required) 3. Has known allergy to gelatin sponge 4. Is unwilling to receive blood products 5. Has liver enzymes appropriate for the study, considering their disease 6. Has appropriate level of platelets per liter (PLT/L) during screening 7. Has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the Investigator, or baseline abnormalities during screening that are not explained by current drug treatment (e.g., warfarin, heparin)
References
Publications (2)
- DERIVEDGupta N, Chetter I, Hayes P, O-Yurvati AH, Moneta GL, Shenoy S, Pribble JP, Zuckerman LA. Randomized trial of a dry-powder, fibrin sealant in vascular procedures. J Vasc Surg. 2015 Nov;62(5):1288-95. doi: 10.1016/j.jvs.2015.05.038. Epub 2015 Aug 5. PMID 26254451
- DERIVEDBochicchio GV, Gupta N, Porte RJ, Renkens KL, Pattyn P, Topal B, Troisi RI, Muir W, Chetter I, Gillen DL, Zuckerman LA, Frohna PA. The FINISH-3 trial: a phase 3, international, randomized, single-blind, controlled trial of topical fibrocaps in intraoperative surgical hemostasis. J Am Coll Surg. 2015 Jan;220(1):70-81. doi: 10.1016/j.jamcollsurg.2014.09.019. Epub 2014 Oct 13. PMID 25458801