NCT01256164 is a NA clinical trial of Fibrocaps (fibrin sealant) in Postoperative Hemorrhage, sponsored by Mallinckrodt.

Who is sponsoring NCT01256164?

NCT01256164 is sponsored by Mallinckrodt.

What drugs are being tested in NCT01256164?

Interventions in NCT01256164: Fibrocaps (fibrin sealant), Gelfoam.

What condition does NCT01256164 study?

NCT01256164 studies Postoperative Hemorrhage.

Is NCT01256164 still recruiting?

NCT01256164 is currently completed. Last updated 14 August 2017.

Are results published for NCT01256164?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-08-14 · How we verify

NCT01256164

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A U.S. Phase 2, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety Study of Topical Fibrocaps™ and Gelatin Sponge (USP) in Surgical Hemostasis

Completed NA Results posted Last updated 14 August 2017

What this trial tests

NA trial testing Fibrocaps (fibrin sealant) in Postoperative Hemorrhage in 70 participants. Completed in 1 October 2011.

Timeline

1 December 2010

Primary endpoint
1 September 2011

1 October 2011

Quick facts

Lead sponsor	Mallinckrodt
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	70
Start date	1 December 2010
Primary completion	1 September 2011
Estimated completion	1 October 2011
Sites	1 location across United States

Drugs / interventions tested

Fibrocaps (fibrin sealant) — full drug profile →
Gelfoam — full drug profile →

Conditions studied

Postoperative Hemorrhage — all drugs for Postoperative Hemorrhage →

Sponsor

Mallinckrodt — full company profile →

Who can join

18 and older, any sex, with Postoperative Hemorrhage. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Mean Time to Hemostasis (TTH)
Time frame: 0-10 minutes
Time to hemostasis recorded from the first application of study treatment until cessation of bleeding

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The role of sealants for achieving anastomotic hemostasis in vascular surgery.
Ma GW, Kucey A, Tyagi SC, Papia G, et al · · 2024 · cited 4× · PMID 38695613 · DOI 10.1002/14651858.cd013421.pub2

Verify or expand the search:

Other Mallinckrodt trials

Trials by the same sponsor.

NCT04169061 — Impact of Acthar on Everyday Life of Participants With Severe Keratitis · Phase 4 · completed
NCT03712280 — MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy) · Phase 2 · completed
NCT03656692 — Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer) · Phase 4 · terminated
NCT03320070 — Acthar Gel in Participants With Pulmonary Sarcoidosis · Phase 4 · completed
NCT03132428 — Registry to Evaluate INOmax in Newborn Babies With Pulmonary Hypertension · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01256164 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mallinckrodt
Last refreshed: 14 August 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01256164.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing