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| Name | Class |
|---|---|
| Tampere Heart Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enoxaparin 40 mg s.c. | Active Comparator | Subcutaneous enoxaparin (Klexane®, Sanofi-Aventis) 40 mg thromboprophylaxis every 24 hours for three days (72 hours) |
|
| Enoxaparin 40 mg i.v. | Active Comparator | Enoxaparin thromboprophylaxis (40 mg) daily as continuous intravenous infusion for three days (72 hours) |
|
| Enoxaparin 0.5 mg/kg s.c. | Active Comparator | Subcutaneous enoxaparin (Klexane®, Sanofi-Aventis) 0.5 mg/kg thromboprophylaxis twice a day for three days (72 hours) |
|
| Enoxaparin 1 mg/kg i.v. | Active Comparator | Enoxaparin thromboprophylaxis 1 mg/kg daily as continuous intravenous infusion for three days (72 hours) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-Xa concentration maximum 0-24h (Cmax0-24h) | Anti-Xa concentration maximum level calculated from measured values during 0-24h after initiation of enoxaparin. | 0-24h after initiation of enoxaparin |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-Xa concentration maximum 25-72 h (Cmax25-72h) | Anti-Xa concentration maximum level calculated from measured values 25-72h after the initiation of enoxaparin. | 25-72 h after initiation of enoxaparin |
| Anti-Xa trough concentartion at 72 h (C72h) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcomes | Postoperative bleeding, DVT, pulmonary embolism, 90 day mortality | 0-90 days after initiation of enoxaparin |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere University Hospital | Tampere | Pirkanmaa | 33521 | Finland |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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Anti-Xa concentration at the of 72h study period
| 72 h after the initiation of enoxaparin |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D002241 |
| Carbohydrates |