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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 is a Phase 3 study that has completed, run by Mallinckrodt. The registered enrollment target is 721 participants.

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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.

Interventions

  • BIOLOGICAL Fibrocaps
  • BIOLOGICAL Gelatin sponge

Trial Details

FieldValue
Enrollment Target 721 participants
Start Date 2012-05-21
Est. Completion 2013-06-01
Phase Phase 3

Sponsor

Mallinckrodt

69 total trials

What the Registry Record Tells You About NCT01527357

The ClinicalTrials.gov registry entry for NCT01527357 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 721 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mallinckrodt, which has 69 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Fibrocaps is the first listed.

NCT01527357 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.