Individualised versus conventional enoxaparin dosing: a randomised controlled trial
A randomised controlled trial to investigate whether an individualised dosage of enoxaparin reduces the incidence of minor and major bleeding when compared to conventional dosing in patients receiving treatment doses of enoxaparin for cardiovascular disease
School of Pharmacy
140 participants
Dec 1, 2009
Interventional
Conditions
Summary
Enoxaparin is a low molecular weight heparin (LMWH) widely used in clinical practice (e.g. heart attacks, and clots in the lungs. It has been proven to be a safe and effective alternative to the traditional unfractionated heparin (UFH). Unlike UFH where dose is monitored, enoxaparin is given on a weight-based regime, without any monitoring. The safety of this dosing regimen of enoxaparin is not well established particularly in patients who are obese or have kidney disease. The effect of enoxaparin can be monitored by measuring a serum protein (anti-Xa). It is known that there is an increased rate of bleeding complications if the anti-Xa concentration is higher than 1000 IU/L. We wish to undertake a randomised controlled trial of patients admitted to Dunedin Hospital who are treated with enoxaparin. Patients will be randomly assigned to either a conventional dosing regimen or a pharmacokinetically-guided dosing regimen. The main endpoints are minor and major bleeding events as defined in the literature (Antman et al. Circulation 1999; 100(15):1593-601). The conventional dosing regimen for all patients will be that determined by the prescribing doctor (as per the product’s license). For the pharmacokinetically-guided dosing regimen, the initial dosing regimen is one chosen by the prescribing doctor. Subsequent doses will be calculated using the anti-Xa concentration obtained from blood samples.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Patients will be randomly assigned to either a conventional dosing regimen or a pharmacokinetically-guided dosing regimen. The amount of the first dose will be at the discretion of the prescribing doctor. Patients will be enrolled by an investigator at the start of their enoxaparin treatment. The pharmacokinetically-guided dosing regimen involves the following: 1. Initial dose as normal (please see below) 2. A blood sample will be collected 2-6 hours after the dose 3. enoxaparin concentration determined by measuring anti-factor Xa concentration in the sample 4. a pharmacokinetic (PK) analysis, based on enoxaparin concentration, will be carried out to estimate concentration-time profile 5. a subsequent dose will be recommended based on the PK analysis such that peak concentrations are over 500 IU/L and trough concentrations are below 500 IU/L. Current criteria for initial dose are: 1. Venous thromboembolism (VTE) 1 mg/kg twice a day or 1.5 mg/kg daily based on total body weight (TBW) 2. Non-ST-elevation acute coronary syndrome 1 mg/kg twice a day based on TBW 3. Severe renal impairment CLCR < 30 ml/min* = 1 mg/kg daily based on TBW The range of dosage for each regimen is: In a conventional dosing regimen, enoxaparin dose is based on total body weight. That is, a 40 kg patient without severe renal impairment would receive 40 mg twice daily; a 40 kg patient with severe renal impairment would receive 40 mg once daily; a 140 kg patient without severe renal impairment would receive 140 mg twice daily; and a 140 kg patient with severe renal impairment would receive 140 mg once daily. In a pharmacokinetically-guided dosing regimen, enoxaparin dose is based on patient demographics and enoxaparin concentration. The dose is unlikely to fall outside the range above (40-140 mg) but details are patient-specific and unavailable at this stage. For both regimens enoxaparin is administered subcutaneously Duration of intervention: While on enoxaparin treatment (usually 2-8 days) Duration of the overall intervention: While on enoxaparin treatment (2-8 days). Patients will be followed up for up to 30 days after the commencement of treatment in order to monitor evidence of therapeutic outcomes and events such as revascularisation, re-thrombosis, or repeat emboli.
Locations(2)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12608000573358