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Assessment of International Normalized Ratio (INR) Prolongation in Patients Treated Simultaneously With Warfarin and Cephalosporins

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01857050
First Posted: May 20, 2013
Last Update Posted: February 25, 2014
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.
Information provided by (Responsible Party):
Meir Medical Center
  Purpose
Many drug interactions with Warfarin are well documented in the literature, including interactions with a variety of antibiotics. However,in mamy cases it is difficult to predict when the interaction remains theoretical and when it becomes clinically significant and will be reflected in the individual patient. This study's aim is to identify and characterize related conditions (including comorbidities, laboratory test results and other parameters related to the patient)that might be predictors for drug interactions turning from theoretical to clinically significant.

Condition
Venous Thrombosis Pulmonary Embolism Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Assessment of INR Prolongation in Patients Treated Simultaneously With Warfarin and Antibiotics From the Cephalosporins Family,Observational Retrospective Study.

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Reasons for INR prolongation in patients who were treated with the combination of Warfarin and Cephalosporins [ Time Frame: Participants will be followed for the duration of thei hospital stay, an expected average of 7 days ]

Enrollment: 236
Study Start Date: April 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Warfarin-treated patients who were hospitalized for any reason in the department of internal medicine and were treated with antibiotics from the Cephalosporins group during their hospitalization.
Criteria

Inclusion Criteria:

  • Patients aged 18 and over
  • Patients treated with a combination of Warfarin and Cephalosporins
  • Patients who were hospitalized in the department of internal medicine
  • Patients who were treated with Warfarin without Cefalosporins

Exclusion Criteria:

  • Patients on Warfarin who did not actually receive the drug during their hospitalization
  • Patients whose medical records were not accessible or didn't contain full data
  Contacts and Locations
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): NCT01857050


Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Michael Lishner, MD Meir Hospital, Kfar Saba, Israel
  More Information

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01857050     History of Changes
Other Study ID Numbers: MMC130210-12CTIL
First Submitted: May 16, 2013
First Posted: May 20, 2013
Last Update Posted: February 25, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Atrial Fibrillation
Thrombosis
Embolism
Pulmonary Embolism
Venous Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Warfarin
Cephalosporins
Anticoagulants
Anti-Bacterial Agents
Anti-Infective Agents