Clinical trial NCT02474212: : Pharmacokinetics of Enoxaparin After Coronary Artery Bypass Graft Surgery
Official title: Anti-Xa Concentrations With Continuous Intravenous Infusion and Subcutaneous Administration of Enoxaparin After Coronary Artery Bypass Grafting: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Venous Thromboembolism
Pulmonary Embolism
Thromboprophylaxis
Keywords: Venous thromboembolism
pulmonary embolism
thromboprophylaxis
anticoagulant
anti-FXa
low-molecular weight heparin
enoxaparin
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Heart Hospital, Tampere University Hospital
First posted: 2015-06-17
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: This is a prospective, randomized, controlled trial. After informed consent, 80 elective on pump CABG patients with a clinical indication for post-operative thromboprophylaxis will be studied in the Tampere University Heart Hospital. Study has two independent parts with 40 patients in both. Results are reported separately from these two parts of the study.

Firts part of the study: After written consent, 20+20 patients are randomized to receive enoxaparin either as continuous intravenous infusion (treatment group) or subcutaneous bolus injection (control group). Enoxaparin dose is 40mg/24h either CIV of SCB. Anti-Xa values are measured 12-14 times from blood samples to evaluate the anticoagulation effect of enoxaparin.

Second part of the study: After written consent, 20+20 patients are randomized to receive enoxaparin either as continuous intravenous infusion (treatment group) or subcutaneous bolus injection (control group). Enoxaparin dose is 1mg/kg/24h in CIV group and 0,5mg/kg twice a day in SCB group. In this second part of the study with eleveted enoxaparin dosage, 4 additional blood samples will be taken and analysed by ROTEM to investigate the overall coagulation status of the patients before and after the initiation of enoxaparin.

The study will consist of two independent parts.

Eligibility 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

Primary outcomes:
measure: Anti-Xa concentration maximum 0-24h (Cmax0-24h)
timeFrame: 0-24h after initiation of enoxaparin
Secondary outcomes:
measure: Anti-Xa concentration maximum 25-72 h (Cmax25-72h)
timeFrame: 25-72 h after initiation of enoxaparin
measure: Anti-Xa trough concentartion at 72 h (C72h)
timeFrame: 72 h after the initiation of enoxaparin
Other outcomes:
measure: Clinical outcomes
timeFrame: 0-90 days after initiation of enoxaparin
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
Study officials:
References: