The DIEP Flap as a Model of Ischemia-Reperfusion: an Inte... | NCT00821158

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

NCT00821158

Sponsor

Maastricht University Medical Center

Status

Unknown status

Last Update Posted

Jan 13, 2009Estimated

Enrollment

30Estimated

Phase

Phase 3

Conditions

Ischemia-Reperfusion

Interventions

Antioxidant
Placebo
Anti-inflammatory drug

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Feb 2011Estimated

Completion Date

Not provided

First Submitted Date

Jan 12, 2009

First Submission Date that Met QC Criteria

Jan 12, 2009

First Posted Date

Jan 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2009

Last Update Posted Date

Jan 13, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators will examine whether administration of certain medications will decrease or prevent ischemia-reperfusion injury.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	Placebo tablet and iv	Other: Placebo
2	Experimental	Placebo tablet and intervention iv	Drug: Antioxidant
3	Experimental	Intervention tablet and placebo iv	Drug: Anti-inflammatory drug

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antioxidant	Drug	Antioxidant iv bolus	2
Placebo

Measure	Description	Time Frame
Antioxidant concentrations		0,5-24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing breast reconstruction

Exclusion Criteria:

Diabetes mellitus
Kidney or liver disease
Use of immunosuppressants

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

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

Overall Officials

Name	Affiliation	Role
R. van der Hulst, M.D., Phd	Maastricht Universtity Medical Center	Study Chair
Marieke van den Heuvel, M.D.	Maastricht University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Medical Center		Maastricht		P.O. Box 5800, 6202 AZ	Netherlands

Intervention Browse Module

MeSH Terms

ID	Term
D000975	Antioxidants
D000893	Anti-Inflammatory Agents

Ancestor Terms

ID	Term
D001685	Biological Factors
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided