: Pharmacokinetics of Enoxaparin After Coronary Artery Bypass Graft Surgery

  • STATUS
    Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    80
  • sponsor
    Tampere University Hospital
Updated on 11 March 2021
enoxaparin

Summary

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.

Description

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.

Details
Condition Pulmonary Disease, Venous Thromboembolism, Pulmonary Embolism, Thromboembolism, Thromboprophylaxis, Lung Disease, lung embolism
Treatment Enoxaparin
Clinical Study IdentifierNCT02474212
SponsorTampere University Hospital
Last Modified on11 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 90 yrs?
Gender: Male or Female
Do you have any of these conditions: Venous Thromboembolism or Thromboprophylaxis or Pulmonary Embolism?
Do you have any of these conditions: lung embolism or Lung Disease or Thromboembolism or Pulmonary Disease or Pulmonary Embolism or Thromboprophylaxis or Venous Thromboembolism?
Do you have any of these conditions: Thromboembolism or Pulmonary Disease or Thromboprophylaxis or Lung Disease or lung embolism or Venous Thromboembolism or Pulmonary Embolism?
Do you have any of these conditions: Pulmonary Embolism or Pulmonary Disease or lung embolism or Thromboembolism or Lung Disease or Thromboprophylaxis or Venous Thromboembolism?
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

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
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