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NCT Number: NCT02474212

: Pharmacokinetics of Enoxaparin After Coronary Artery Bypass Graft Surgery

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.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Thromboprophylaxis Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tampere University Hospital

Tampere, Pirkanmaa, 33521, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Enoxaparin

Drug

Primary outcomes

  1. Anti-Xa concentration maximum 0-24h (Cmax0-24h)

    Time frame: 0-24h after initiation of enoxaparin

    Anti-Xa concentration maximum level calculated from measured values during 0-24h after initiation of enoxaparin.

Secondary outcomes

  1. Anti-Xa concentration maximum 25-72 h (Cmax25-72h)

    Time frame: 25-72 h after initiation of enoxaparin

    Anti-Xa concentration maximum level calculated from measured values 25-72h after the initiation of enoxaparin.

  2. Anti-Xa trough concentartion at 72 h (C72h)

    Time frame: 72 h after the initiation of enoxaparin

    Anti-Xa concentration at the of 72h study period

Other outcomes

  1. Clinical outcomes

    Time frame: 0-90 days after initiation of enoxaparin

    Postoperative bleeding, DVT, pulmonary embolism, 90 day mortality

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Tampere Heart Hospital

Registry information

Official study title

Anti-Xa Concentrations With Continuous Intravenous Infusion and Subcutaneous Administration of Enoxaparin After Coronary Artery Bypass Grafting: Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Jun 17, 2015
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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