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Study of Recombinant Human Thrombin for Bleeding During Surgery

NCT00245336 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 401

Last updated 2009-03-09

No results posted yet for this study

Summary

The purpose of this study is to determine whether recombinant human Thrombin (rhThrombin) is effective in stopping bleeding during surgery, in comparison with bovine thrombin.

Conditions

  • Surgical Hemostasis

Interventions

BIOLOGICAL

rThrombin

1000 U/mL applied topically in combination with absorbable gelatin sponge

DRUG

bovine thrombin

1000 U/mL applied topically in combination with absorbable gelatin sponge

Sponsors & Collaborators

  • ZymoGenetics

    lead INDUSTRY

Principal Investigators

  • Thomas C Reynolds, MD, PhD · ZymoGenetics

  • William Chapman, MD · Washington University School of Medicine

  • Kenneth Renkens, MD · Indiana Spine Group

  • Fred Weaver, MD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2006-06-30
Completion
2006-07-31

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 NCT00245336 on ClinicalTrials.gov