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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01857050
First received: May 16, 2013
Last updated: February 24, 2014
Last verified: February 2014

May 16, 2013
February 24, 2014
April 2013
January 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01857050 on ClinicalTrials.gov Archive Site
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Assessment of International Normalized Ratio (INR) Prolongation in Patients Treated Simultaneously With Warfarin and Cephalosporins
Assessment of INR Prolongation in Patients Treated Simultaneously With Warfarin and Antibiotics From the Cephalosporins Family,Observational Retrospective Study.

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.

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Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Non-Probability Sample

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.

  • Venous Thrombosis
  • Pulmonary Embolism
  • Atrial Fibrillation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
236
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01857050
MMC130210-12CTIL
No
Meir Medical Center
Meir Medical Center
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Principal Investigator: Michael Lishner, MD Meir Hospital, Kfar Saba, Israel
Meir Medical Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP