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Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis

NCT ID: NCT00813904

Last Updated: 2011-12-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-07-31

Brief Summary

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The objective of this study is to assess the immunogenicity and safety of recombinant Thrombin (rThrombin) in patients with prior rThrombin exposure.

Detailed Description

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The safety, immunogenicity, and efficacy of rThrombin have been evaluated in Phase 2 and Phase 3 studies in the following surgical indications: spinal surgery, major hepatic resection, peripheral arterial bypass (PAB) surgery, arteriovenous (AV) graft formation for hemodialysis access, and skin graft surgery following burn injury. Limited data on rThrombin reexposure currently exist. This study will assess the immunogenicity and safety of rThrombin in participants who are undergoing a surgical procedure during which topical rThrombin application is planned and who previously received rThrombin in Phase 3 clinical trials or during prior spine, AV graft formation, or PAB surgical procedures.

Conditions

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Blood Loss, Surgical

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rThrombin, 1000 IU/mL

Group Type EXPERIMENTAL

rThrombin, 1000 IU/mL

Intervention Type BIOLOGICAL

At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site, per product labeling.

Interventions

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rThrombin, 1000 IU/mL

At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site, per product labeling.

Intervention Type BIOLOGICAL

Other Intervention Names

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RECOTHROM

Eligibility Criteria

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Inclusion Criteria

* Previous enrollment in a ZymoGenetics-sponsored Phase 3 study and the recipient of treatment with rThrombin in that study or the recipient of commercially-available rThrombin in a prior spine, arteriovenous graft formation, or peripheral artery bypass surgical procedure
* Age of 18 years or older at time of consent
* Bleeding indicating treatment with rThrombin during the course of the surgical procedure
* Signed informed consent document approved by an institutional review board or independent ethics committee

Exclusion Criteria

* Currently undergoing a procedure requiring cardiopulmonary bypass or involving the aortic arch
* Known hypersensitivity to rThrombin product or any of its components
* Currently undergoing a surgical procedure where the use of other thrombin-containing hemostatic agents is planned
* Medical, social, or psychosocial factors that, in the opinion of the investigator, could affect the participant's safety or compliance with study procedures
* Treatment with any experimental agent within 30 days of study enrollment or treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZymoGenetics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil Singla, MD

Role: PRINCIPAL_INVESTIGATOR

Lotus Clinical Research

Locations

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Tuscon Orthopaedic Institute

Tuscon, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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499G02

Identifier Type: -

Identifier Source: org_study_id