Pulmonary Embolism, Thromboprophylaxis, Venous Thromboembolism
Conditions
Keywords
Venous thromboembolism, pulmonary embolism, thromboprophylaxis, anticoagulant, anti-FXa, low-molecular weight heparin, enoxaparin
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.
Interventions
DRUGEnoxaparin
Sponsors
Heart Hospital, Tampere University Hospital
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Xa concentration maximum 0-24h (Cmax0-24h) | 0-24h after initiation of enoxaparin | Anti-Xa concentration maximum level calculated from measured values during 0-24h after initiation of enoxaparin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Xa concentration maximum 25-72 h (Cmax25-72h) | 25-72 h after initiation of enoxaparin | Anti-Xa concentration maximum level calculated from measured values 25-72h after the initiation of enoxaparin. |
| Anti-Xa trough concentartion at 72 h (C72h) | 72 h after the initiation of enoxaparin | Anti-Xa concentration at the of 72h study period |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes | 0-90 days after initiation of enoxaparin | Postoperative bleeding, DVT, pulmonary embolism, 90 day mortality |
Countries
Finland
Outcome results
None listed