NCT01256190 is a Phase 2 clinical trial of Fibrocaps (fibrin sealant) in Postoperative Hemorrhage, sponsored by Mallinckrodt.

Who is sponsoring NCT01256190?

NCT01256190 is sponsored by Mallinckrodt.

What drugs are being tested in NCT01256190?

Interventions in NCT01256190: Fibrocaps (fibrin sealant), Gelatin sponge.

What condition does NCT01256190 study?

NCT01256190 studies Postoperative Hemorrhage.

Is NCT01256190 still recruiting?

NCT01256190 is currently completed. Last updated 22 July 2016.

Are results published for NCT01256190?

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

Last reviewed 2016-07-22 · How we verify

NCT01256190

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

A Phase 2, Randomized, Single-Blind, Controlled, Comparative Efficacy and Safety and Study of Topical Fibrocaps™ and Gelatin Sponge in Surgical Hemostasis in the Netherlands

Completed Phase 2 Results posted Last updated 22 July 2016

What this trial tests

Phase 2 trial testing Fibrocaps (fibrin sealant) in Postoperative Hemorrhage in 56 participants. Completed in 1 October 2011.

Timeline

1 December 2010

Primary endpoint
1 September 2011

1 October 2011

Quick facts

Lead sponsor	Mallinckrodt
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	56
Start date	1 December 2010
Primary completion	1 September 2011
Estimated completion	1 October 2011
Sites	1 location across Netherlands

Drugs / interventions tested

Fibrocaps (fibrin sealant) — full drug profile →
Gelatin sponge — 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.

Time to Hemostasis
Time frame: 0-10 minutes
Time from application of treatment to cessation of bleeding

Sponsor's own description

A multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in subjects undergoing open liver resection surgery. The study will enroll 42 eligible subjects and be conducted at 4 sites in the Netherlands.

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 NCT01256190 (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: 22 July 2016

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/NCT01256190.

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