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Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis

NCT00491608 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2012-01-13

Study results available
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Summary

The purpose of this study is to evaluate the safety and immune system response to recombinant thrombin when used to control bleeding in spinal and vascular surgery.

Conditions

  • Spinal Surgery
  • Vascular Surgery

Interventions

BIOLOGICAL

rThrombin

1000 U/mL applied directly or in combination with absorbable gelatin sponge or powder

Sponsors & Collaborators

  • ZymoGenetics

    lead INDUSTRY

Principal Investigators

  • Allan Alexander, MD, CPI · ZymoGenetics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States

Study Locations

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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 NCT00491608 on ClinicalTrials.gov