Pharmacokinetics of enoxaparin after coronary artery bypass graft surgery

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001127-24-FI

Enrollment

Registered

2015-05-18

Start date

2015-06-03

Completion date

Unknown

Last updated

2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboprophylaxis after coronary artery bypass graft surgery

Interventions

Trade Name: Klexane Product Name: Klexane Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age: 18 to 90 years 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80

Exclusion criteria

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 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
Main Objective: To evaluate the pharmacokinetics of the thromboprophylactic agent enoxaparin in postoperative cardiac surgery patients by comparing plasma anti-Xa activity when enoxaparin is administered either as a continuous intravenous infusion or subcutaneous bolus once or twice daily.;Secondary Objective: To investigate possible overall coagulation status of CABG patients with rotational thromboelastometry (ROTEM) and show starting thromboprophylaxis 6-10 h after the end of operation is safe. ;Primary end point(s): Maximal enoxaparin concentration;Timepoint(s) of evaluation of this end point: 3 hours after the onset of study drug	—

Measure

Time frame

Main Objective: To evaluate the pharmacokinetics of the thromboprophylactic agent enoxaparin in postoperative cardiac surgery patients by comparing plasma anti-Xa activity when enoxaparin is administered either as a continuous intravenous infusion or subcutaneous bolus once or twice daily.;Secondary Objective: To investigate possible overall coagulation status of CABG patients with rotational thromboelastometry (ROTEM) and show starting thromboprophylaxis 6-10 h after the end of operation is safe. ;Primary end point(s): Maximal enoxaparin concentration;Timepoint(s) of evaluation of this end point: 3 hours after the onset of study drug

—

Secondary

Measure	Time frame
Secondary end point(s): mortality 90 d, bleeding (E-CABG bleeding score) or venous thromboembolism (compression ultrasound on a day 3) ROTEM samples at 3 and 12 h after the beginning of the enoxaparin administration;Timepoint(s) of evaluation of this end point: 90 days after study period	—

Countries

Finland

Contacts

Public ContactTampere Heart Hospital

Tampere Heart Hospital

kati.jarvela@sydansairaala.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026