Pharmacokinetics of Pavaverine After Intraluminal Administration

Complications Due to Coronary Artery Bypass Graft Clinical Trial

Official title:

Observational Study on Papaverine During Cardiac Surgical Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436981
• Other study ID #: PAV002-AHK
• Status: Completed
• Phase: N/A
• First received: September 14, 2011
• Last updated: June 3, 2013
• Start date: October 2012
• Est. completion date: January 2013

Study information

• Verified date: June 2013
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the pharmacokinetic of papaverine after administration into the artery mammaria interna.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• CABG

• Administration of papaverine into mammaria interna

Exclusion Criteria:

• Allergy against papaverine

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Complications Due to Coronary Artery Bypass Graft
• Injury of Internal Mammary Artery

Intervention

Procedure:
• CABG
Preparation of artery mammaria interna

Locations

Country	Name	City	State
Germany	Klinikum der Goethe Universität Frankfurt	Frankfurt am Main	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals	Klinikum Ludwigshafen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration of papaverine	Serum probes will be analysed for the concentrations of papaverine.	4 hours	No