Pharmacokinetics of enoxaparin after coronary artery bypass graft surgery

Phase 1

• Conditions: Thromboprophylaxis after coronary artery bypass graft surgery; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-001127-24-FI
• Lead Sponsor: Tampere Heart Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-18
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): mortality 90 d, bleeding (E-CABG bleeding score) or venous thromboembolism (compression ultrasound on a day 3)<br>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