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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 May 2023 |
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Main ID: |
NCT02474212 |
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Date of registration:
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15/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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: Pharmacokinetics of Enoxaparin After Coronary Artery Bypass Graft Surgery
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Scientific title:
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Anti-Xa Concentrations With Continuous Intravenous Infusion and Subcutaneous Administration of Enoxaparin After Coronary Artery Bypass Grafting: Randomized Clinical Trial |
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Date of first enrolment:
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May 2016 |
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Target sample size:
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85 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02474212 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Finland
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- BMI between 18-33 kg/m2
- Elective on-pump CABG operation
- Indication for post-operative pharmacological thromboprophylaxis
- Written informed consent obtained from the patient or his/her legal representative.
Exclusion Criteria:
- Other indications for anticoagulant therapy than thromboprophylaxis
- Known heparin induced thrombocytopenia (HIT), or hypersensitivity to enoxaparin or
heparin
- Any long-term anticoagulant medication, expect low-dose aspirin
- Major bleeding within the last week unless definitively treated
- Blood platelet count <20, P-TT <20 % or INR >1.7
- GFR less than 30 ml/min/1.73 m2 estimated from serum creatinine by applying
Cockcroft-Gault equation 13 or chronic dialysis
- Known HIV, HBV, or HCV infection
- Pregnancy
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Venous Thromboembolism
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Thromboprophylaxis
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Pulmonary Embolism
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Intervention(s)
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Drug: Enoxaparin
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Primary Outcome(s)
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Anti-Xa concentration maximum 0-24h (Cmax0-24h)
[Time Frame: 0-24h after initiation of enoxaparin]
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Secondary Outcome(s)
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Anti-Xa concentration maximum 25-72 h (Cmax25-72h)
[Time Frame: 25-72 h after initiation of enoxaparin]
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Anti-Xa trough concentartion at 72 h (C72h)
[Time Frame: 72 h after the initiation of enoxaparin]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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