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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00775398
Other study ID # K847-08-4003
Secondary ID
Status Completed
Phase N/A
First received October 16, 2008
Last updated June 6, 2012
Start date November 2008
Est. completion date November 2009

Study information

Verified date June 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess the effect of possible exposure to THROMBIN JMI® on activated partial thromboplastin time (aPTT) at 48 hours post surgery in subjects with likelihood of prior exposure to THROMBIN JMI® within the past 4 years.


Description:

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Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change from Baseline in aPTT at 48 hours post surgery Pre-surgery, 48 hours post-surgery Yes
Secondary Changes from Baseline in specified antibody levels at 48 hours, 4 weeks, and 8 weeks post-surgery Pre-surgery, 48 hours, 4 weeks, 8 weeks post-surgery No
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