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Antibiotic-associated Coagulopathy

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ClinicalTrials.gov Identifier: NCT02172833
Recruitment Status : Unknown
Verified December 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : June 24, 2014
Last Update Posted : January 1, 2015
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief 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 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.

Condition or disease
Infection Blood Coagulation Disorders

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Antibiotic-associated Coagulopathy
Study Start Date : January 2014
Estimated Primary Completion Date : July 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
Criteria

Inclusion Criteria:

  • patients aged older than 20 years old
  • using antibiotics for more than 48 hours in the emergency department

Exclusion Criteria:

  • shift of antibiotic prescription in the ER
  • patients with hemorrhage -related diagnoses
  • non-temporally consecutive referral from the ER to the ward

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 ClinicalTrials.gov identifier (NCT number): NCT02172833


Contacts
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Contact: Shu-Wen Lin, Pharm.D. +886-2-3366-8782 shuwenlin@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Shu-Wen Lin, Pharm.D.    +886-2-3366-8782    shuwenlin@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Shu-Wen Lin, Pharm.D. National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02172833    
Other Study ID Numbers: 201312061RINB
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: January 1, 2015
Last Verified: December 2014
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Anti-Bacterial Agents
Anti-Infective Agents