Venous ThrombosisNCT01857050
Assessment of International Normalized Ratio (INR) Prolongation in Patients Treated Simultaneously With Warfarin and Cephalosporins
An observational study of Venous Thrombosis and Pulmonary Embolism, run by Meir Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation
- How many people
- 236 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Reasons for INR prolongation in patients who were treated with the combination of Warfarin and Cephalosporins
Measured: Participants will be followed for the duration of thei hospital stay, an expected average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Lishner, MD, Principal investigator, Meir Hospital, Kfar Saba, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857050
- Sponsor's protocol ID
- MMC130210-12CTIL
- Status last verified
- Feb 2014
- First submitted
- 16 May 2013
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of INR Prolongation in Patients Treated Simultaneously With Warfarin and Antibiotics From the Cephalosporins Family,Observational Retrospective Study.
- ClinicalTrials.gov ID
- NCT01857050
- Acronym / sponsor ID
- MMC130210-12CTIL
- Conditions
- Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 20 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Lishner, MD principal investigator
Meir Hospital, Kfar Saba, Israel
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thrombosis and Pulmonary Embolism, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2014.