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

This study has been completed.
Information provided by (Responsible Party):
Meir Medical Center Identifier:
First received: May 16, 2013
Last updated: February 24, 2014
Last verified: February 2014
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.

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)

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01857050

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

Responsible Party: Meir Medical Center Identifier: NCT01857050     History of Changes
Other Study ID Numbers: MMC130210-12CTIL
Study First Received: May 16, 2013
Last Updated: February 24, 2014

Additional relevant MeSH terms:
Atrial Fibrillation
Pulmonary Embolism
Venous Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents processed this record on September 19, 2017