InfectionNCT02172833
Antibiotic-associated Coagulopathy
An observational study of Infection and Blood Coagulation Disorders, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Over the past few decades, a good number of studies with regard to coagulopathy and increased bleeding tendency which is defined as macro- or microscopic hemorrhage, declination of hemoglobin level, thrombocytopenia, and hypoprothrombinemia potentially caused by the use of antibiotics through a variety of suggested… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Infection, Blood Coagulation Disorders
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Jul 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged older than 20 years old using antibiotics for more than 48 hours in the emergency department in National Taiwan University Hospital and in in LHID 2000, 2005, and 2010 cohort derived from National Health Insurance Research Database
Who may be able to join
- patients aged older than 20 years old
- using antibiotics for more than 48 hours in the emergency department
Who cannot join
- shift of antibiotic prescription in the ER
- patients with hemorrhage -related diagnoses
- non-temporally consecutive referral from the ER to the ward
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Shu-Wen Lin, Pharm.D., +886-2-3366-8782, shuwenlin@ntu.edu.tw
About this study
Over the past few decades, a good number of studies with regard to coagulopathy and increased bleeding tendency which is defined as macro- or microscopic hemorrhage, declination of hemoglobin level, thrombocytopenia, and hypoprothrombinemia potentially caused by the use of antibiotics through a variety of suggested mechanisms, including myelosuppression, immune-mediated destruction of thrombocytes and coagulation factors, and suppression of vitamin K epoxide reductase or vitamin K-dependent γ-glutamate carboxylase which may lead to inhibition of biosynthesis of coagulation factor II, VII, IX, and X, have been reported or published. Nevertheless, many of them are case-series studies or case reports with low level of evidence, and there have been no large-scale retrospective cohort studies regarding antibiotic-associated coagulopathy being published. Moreover, in addition to exposure to antibiotics, there are several risk factors, including severity of illness, hepatic or renal function, nutrition status, comorbidities such as cancer and hematologic disease, surgery or other invasive procedure, concomitant use of anticoagulants, NSAIDs, and salicylates, and age, which may exert influence on the function of the coagulation system as well. Therefore, the study aims to clarify the association between the use of antibiotics and the increase of bleeding tendency or the development of bleeding event and to identify possible risk factors of the increase of bleeding tendency or the development of bleeding event in patients receiving antibiotic treatment through the application of nested case-control design and the usage of both the National Health Insurance Research Database (NHIRD) and medical records in National Taiwan University Hospital during the time period from January, 1995 to December, 2013.
- Conditions
- Infection, Blood Coagulation Disorders
- Medical subject headings
- Infections, Blood Coagulation Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
development of any bleeding episodes as confirmed by ICD-9-CM code or use of vit. K1, fresh frozen plasma, or coagulation factors II, VII, XI, X
Measured: within 7 days post antibiotics use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-Wen Lin, Pharm.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172833
- Sponsor's protocol ID
- 201312061RINB
- Status last verified
- Dec 2014
- First submitted
- 22 Jun 2014
- Last updated
- 1 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic-associated Coagulopathy
- ClinicalTrials.gov ID
- NCT02172833
- Acronym / sponsor ID
- 201312061RINB
- Conditions
- Infection, Blood Coagulation Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2015 (estimated)
- First posted
- 24 Jun 2014 (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.
Over the past few decades, a good number of studies with regard to coagulopathy and increased bleeding tendency which is defined as macro- or microscopic hemorrhage, declination of hemoglobin level, thrombocytopenia, and hypoprothrombinemia potentially caused by the use of antibiotics through a variety of suggested mechanisms, including myelosuppression, immune-mediated destruction of thrombocytes and coagulation factors, and suppression of vitamin K epoxide reductase or vitamin K-dependent γ-glutamate carboxylase which may lead to inhibition of biosynthesis of coagulation factor II, VII, IX, and X, have been reported or published. Nevertheless, many of them are case-series studies or case reports with low level of evidence, and there have been no large-scale retrospective cohort studies regarding antibiotic-associated coagulopathy being published. Moreover, in addition to exposure to antibiotics, there are several risk factors, including severity of illness, hepatic or renal function, nutrition status, comorbidities such as cancer and hematologic disease, surgery or other invasive procedure, concomitant use of anticoagulants, NSAIDs, and salicylates, and age, which may exert influence on the function of the coagulation system as well. Therefore, the study aims to clarify the association between the use of antibiotics and the increase of bleeding tendency or the development of bleeding event and to identify possible risk factors of the increase of bleeding tendency or the development of bleeding event in patients receiving antibiotic treatment through the application of nested case-control design and the usage of both the National Health Insurance Research Database (NHIRD) and medical records in National Taiwan University Hospital during the time period from January, 1995 to December, 2013.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged older than 20 years old using antibiotics for more than 48 hours in the emergency department in National Taiwan University Hospital and in in LHID 2000, 2005, and 2010 cohort derived from National Health Insurance Research Database
Key inclusion criteria (2 listed)
- patients aged older than 20 years old
- using antibiotics for more than 48 hours in the emergency department
Key exclusion criteria (3 listed)
- shift of antibiotic prescription in the ER
- patients with hemorrhage -related diagnoses
- non-temporally consecutive referral from the ER to the ward
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
development of any bleeding episodes as confirmed by ICD-9-CM code or use of vit. K1, fresh frozen plasma, or coagulation factors II, VII, XI, X
Time frame: within 7 days post antibiotics use
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2015.
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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.
Shu-Wen Lin, Pharm.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and Blood Coagulation Disorders, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Wen Lin, Pharm.D. (+886-2-3366-8782, shuwenlin@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
development of any bleeding episodes as confirmed by ICD-9-CM code or use of vit. K1, fresh frozen plasma, or coagulation factors II, VII, XI, X (time frame: within 7 days post antibiotics use). 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 1 Jan 2015.