NCT00821158

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2009

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Last Updated

January 13, 2009

Status Verified

January 1, 2009

Enrollment Period

2 years

First QC Date

January 12, 2009

Last Update Submit

January 12, 2009

Conditions

Ischemia-Reperfusion

Outcome Measures

Primary Outcomes (1)

  • Antioxidant concentrations

    0,5-24 hours

Study Arms (3)

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

AntioxidantDRUG

Antioxidant iv bolus

2
PlaceboOTHER

Placebo tablet and iv

1
Anti-inflammatory drugDRUG

Anti-inflammatory tablet

3

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing breast reconstruction

You may not qualify if:

  • Diabetes mellitus
  • Kidney or liver disease
  • Use of immunosuppressants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, P.O. Box 5800, 6202 AZ, Netherlands

Location

MeSH Terms

Interventions

AntioxidantsAnti-Inflammatory Agents

Intervention Hierarchy (Ancestors)

Biological FactorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesProtective AgentsPhysiological Effects of DrugsSpecialty Uses of ChemicalsTherapeutic Uses

Study Officials

  • 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

Central Study Contacts

Marieke van den Heuvel, M.D.

CONTACT

0031-43-3875496m.vandenheuvel@ah.unimaas.nl

R. van der Hulst, M.D., Phd

CONTACT

0031-43-3877481r.vander.hulst@mumc.nl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2009

First Posted

January 13, 2009

Study Start

February 1, 2009

Primary Completion

February 1, 2011

Last Updated

January 13, 2009

Record last verified: 2009-01

Locations

NL(1)