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Trial record 15 of 232 for:    warfarin AND International

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

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. Identifier: NCT01857050
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : February 25, 2014
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:
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 or disease
Venous Thrombosis Pulmonary Embolism Atrial Fibrillation

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Study Type : Observational
Actual Enrollment : 236 participants
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.
Study Start Date : April 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Warfarin

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT01857050

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

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Responsible Party: Meir Medical Center Identifier: NCT01857050    
Other Study ID Numbers: MMC130210-12CTIL
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: February 25, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Pulmonary Embolism
Atrial Fibrillation
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