Overview

: Pharmacokinetics of Enoxaparin After Coronary Artery Bypass Graft Surgery

Status:
Recruiting
Trial end date:
2023-03-31
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the pharmacokinetics of thromboprophylactic doses of LMWH enoxaparin in postoperative CABG patients, drug is administered either as a continuous intravenous infusion (CIV) or subcutaneous bolus (SCB) once per 72h. Plasma anti-Xa values are measured 12-14 times during study period and concentration maximums calculated to enable comparison of anti-Xa values between administration routes.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tampere University Hospital
Collaborator:
Tampere University Heart Hospital
Treatments:
Enoxaparin
Criteria
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