Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01527357 · ClinicalTrials.gov registry record · Phase 3
A Study of Fibrocaps™ in Surgical Bleeding
A Phase 3 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 3
- Development phase
- 721
- Enrollment target
NCT01527357: Completed Phase 3 study, sponsored by Mallinckrodt.
NCT01527357 is a Phase 3 study that has completed, run by Mallinckrodt. The registered enrollment target is 721 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01527357, a Phase 3 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 721 participants
- Enrollment target
Study 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.
Primary Outcome
The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.
Interventions
- BIOLOGICAL Fibrocaps
- BIOLOGICAL Gelatin sponge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 721 participants |
| Start Date | 2012-05-21 |
| Est. Completion | 2013-06-01 |
| Phase | Phase 3 |
What the finished NCT01527357 record still lists
NCT01527357 is an interventional study that assigns participants to a tested intervention. The registered 721 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Fibrocaps is the first listed.
NCT01527357 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01527357 about?
NCT01527357 is a clinical study titled "A Study of Fibrocaps™ in Surgical Bleeding". 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 surger...
What is the current status of trial NCT01527357?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 721 participants. The study started on 2012-05-21. Estimated completion is 2013-06-01.
What interventions are being tested in trial NCT01527357?
The interventions under investigation include: Fibrocaps (BIOLOGICAL), Gelatin sponge (BIOLOGICAL).
Who is sponsoring clinical trial NCT01527357?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01527357's enrollment target sits among peer trials
721 494th of 2000 higher than 1,507 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06116149 · 722 participants · NA
Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics
- NCT04916327 · 720 participants · NA
Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1
- NCT05047224 · 720 participants · NA
Addressing Disparities in Autism Spectrum Disorder Diagnosis Using a Direct-to-home Telemedicine Tool
- NCT05309395 · 720 participants · Phase 3
Food Prescriptions to Promote Affordable Diets
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI