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NCT01256164 · ClinicalTrials.gov registry record · NA

U.S. Study of Fibrocaps in Surgical Hemostasis

A NA study, sponsored by Mallinckrodt.

Completed
Registry status
NA
Development phase
70
Enrollment target

NCT01256164: Completed NA study, sponsored by Mallinckrodt.

NCT01256164 is a NA study that has completed, run by Mallinckrodt. The registered enrollment target is 70 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01256164, a NA study, has completed, sponsored by Mallinckrodt.

COMPLETED
Registry status
NA
Development phase
70 participants
Enrollment target

Study Summary

The purpose of this study was to characterize the safety and hemostatic activity of topical Fibrocaps in surgical patients when control of mild to moderate bleeding by standard surgical techniques was ineffective and/or impractical.

Primary Outcome

Time to hemostasis recorded from the first application of study treatment until cessation of bleeding

Interventions

  • DEVICE Fibrocaps (fibrin sealant)
  • DEVICE Gelfoam

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2010-12
Est. Completion 2011-10
Phase NA
Mallinckrodt

69 total trials

What the finished NCT01256164 record still lists

NCT01256164 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

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

NCT01256164 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01256164 about?

NCT01256164 is a clinical study titled "U.S. Study of Fibrocaps in Surgical Hemostasis". The purpose of this study was to characterize the safety and hemostatic activity of topical Fibrocaps in surgical patients when control of mild to moderate bleeding by standard surgical techniques was ineffective and/or impractical.

What is the current status of trial NCT01256164?

This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2010-12. Estimated completion is 2011-10.

What interventions are being tested in trial NCT01256164?

The interventions under investigation include: Fibrocaps (fibrin sealant) (DEVICE), Gelfoam (DEVICE).

Who is sponsoring clinical trial NCT01256164?

This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01256164's enrollment target sits among peer trials

70 1103rd of 2000 higher than 868 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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

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Source: ClinicalTrials.gov NCT01256164, the US trial registry maintained by the National Library of Medicine. NCT01256164 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.