: 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