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Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis

NCT00813904 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2011-12-08

Study results available
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Summary

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

Conditions

  • Blood Loss, Surgical

Interventions

BIOLOGICAL

rThrombin, 1000 IU/mL

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

Sponsors & Collaborators

  • ZymoGenetics

    lead INDUSTRY

Principal Investigators

  • Neil Singla, MD · Lotus Clinical Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00813904 on ClinicalTrials.gov