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
  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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01857050

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

No publications provided

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

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

ClinicalTrials.gov processed this record on April 17, 2014