A Phase 4 interventional study of Enoxaparin in Venous Thromboembolism, Pulmonary Embolism and Thromboprophylaxis, sponsored by Tampere University Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by Tampere University Hospital · Phase 4, Interventional, and Prevention
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.
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
This study's enrollment of 85 is below the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →Tampere University Hospital is the lead sponsor of 209 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
Subcutaneous enoxaparin (Klexane®, Sanofi-Aventis) 40 mg thromboprophylaxis every 24 hours for three days (72 hours)
Drug: Enoxaparin
Enoxaparin thromboprophylaxis (40 mg) daily as continuous intravenous infusion for three days (72 hours)
Drug: Enoxaparin
Subcutaneous enoxaparin (Klexane®, Sanofi-Aventis) 0.5 mg/kg thromboprophylaxis twice a day for three days (72 hours)
Drug: Enoxaparin
Enoxaparin thromboprophylaxis 1 mg/kg daily as continuous intravenous infusion for three days (72 hours)
Drug: Enoxaparin
Anti-Xa concentration maximum 0-24h (Cmax0-24h)
Anti-Xa concentration maximum level calculated from measured values during 0-24h after initiation of enoxaparin.
Time frame: 0-24h after initiation of enoxaparin
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.
Time frame: 25-72 h after initiation of enoxaparin
Anti-Xa trough concentartion at 72 h (C72h)
Anti-Xa concentration at the of 72h study period
Time frame: 72 h after the initiation of enoxaparin
Clinical outcomes
Postoperative bleeding, DVT, pulmonary embolism, 90 day mortality
Time frame: 0-90 days after initiation of enoxaparin
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Tampere University Hospital