Phase 3
N=721
A Study of Fibrocaps™ in Surgical Bleeding
Mild or Moderate Surgical Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT01527357 ↗Enrolled (actual)
721
Serious AEs
15.3%
Results posted
Dec 2019
Primary outcome: Primary: Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery — 1.0; 2.5 minutes — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fibrocaps (Biological); Gelatin sponge (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mallinckrodt
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery |
1.0; 2.5 | < 0.0001 sig |
| PRIMARY Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery |
2.0; 4.0 | < 0.0001 sig |
| PRIMARY Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection |
1.0; 2.0 | < 0.0001 sig |
| PRIMARY Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection |
1.5; 2.5 | < 0.0001 sig |
| SECONDARY Restricted Mean TTH |
1.2; 2.7; 2.4; 3.5; 1.5; 2.5 | — |
| SECONDARY Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) |
426; 214 | — |
| SECONDARY Number of Participants Who Require Alternative Hemostatic Agents at 5 Minutes |
6; 7 | — |
| SECONDARY Number of Participants Who Required Red Blood Cells |
40; 22 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Has signed an institutional review board/independent ethics committee (IRB/IEC)-approved informed consent document
- Is undergoing one of the 4 surgical procedures described
- Is at least 18 years old at time of consent
- If female and of child-bearing potential, has negative pregnancy test during screening and is not breast-feeding
- 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
- Has not received blood transfusion between screening and study treatment
- Has mild to moderate surgical bleeding
- Does not have intra-operative complications
- Has not used a topical hemostat containing thrombin prior to study treatment
- Has an approximate bleeding site surface area of less than or equal to 100 cm^2
Exclusion Criteria
- Has known antibodies or hypersensitivity to thrombin or other coagulation factors
- Has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required)
- Has known allergy to gelatin sponge
- Is unwilling to receive blood products
- Has liver enzymes appropriate for the study, considering their disease
- Has appropriate level of platelets per liter (PLT/L) during screening
- 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)
Data sourced from ClinicalTrials.gov (NCT01527357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.