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The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00821158
Recruitment Status : Unknown
Verified January 2009 by Maastricht University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 13, 2009
Last Update Posted : January 13, 2009
Sponsor:
Information provided by:
Maastricht University Medical Center

Study Description
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Brief Summary:
The investigators will examine whether administration of certain medications will decrease or prevent ischemia-reperfusion injury.

Condition or disease Intervention/treatment Phase
Ischemia-Reperfusion Drug: Antioxidant Other: Placebo Drug: Anti-inflammatory drug Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study
Study Start Date : February 2009
Estimated Primary Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 1
Placebo tablet and iv
 Other: Placebo
Placebo tablet and iv
Experimental: 2
Placebo tablet and intervention iv
 Drug: Antioxidant
Antioxidant iv bolus
Experimental: 3
Intervention tablet and placebo iv
 Drug: Anti-inflammatory drug
Anti-inflammatory tablet


Outcome Measures
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Primary Outcome Measures :
  1. Antioxidant concentrations [ Time Frame: 0,5-24 hours ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing breast reconstruction

Exclusion Criteria:

  • Diabetes mellitus
  • Kidney or liver disease
  • Use of immunosuppressants
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821158


Contacts
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Contact: Marieke van den Heuvel, M.D. 0031-43-3875496 m.vandenheuvel@ah.unimaas.nl
Contact: R. van der Hulst, M.D., Phd 0031-43-3877481 r.vander.hulst@mumc.nl

Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Netherlands, P.O. Box 5800, 6202 AZ
Contact: Marieke van den Heuvel, M.D.    0031-43-3875496    m.vandenheuvel@ah.unimaas.nl   
Principal Investigator: Marieke van den Heuvel, M.D.         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Study Chair: R. van der Hulst, M.D., Phd Maastricht Universtity Medical Center
Principal Investigator: Marieke van den Heuvel, M.D. Maastricht University Medical Center
More Information
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Responsible Party: R. van der Hulst, M.D., Phd, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00821158    
Other Study ID Numbers: MEC 25-11-2008
First Posted: January 13, 2009    Key Record Dates
Last Update Posted: January 13, 2009
Last Verified: January 2009
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes
Anti-Inflammatory Agents
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs