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: Pharmacokinetics of Enoxaparin After Coronary Artery Bypass Graft Surgery

Primary Purpose

Venous Thromboembolism, Pulmonary Embolism, Thromboprophylaxis

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Enoxaparin
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring Venous thromboembolism, pulmonary embolism, thromboprophylaxis, anticoagulant, anti-FXa, low-molecular weight heparin, enoxaparin

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tampere University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Enoxaparin 40 mg s.c.

Enoxaparin 40 mg i.v.

Enoxaparin 0.5 mg/kg s.c.

Enoxaparin 1 mg/kg i.v.

Arm Description

Subcutaneous enoxaparin (Klexane®, Sanofi-Aventis) 40 mg thromboprophylaxis every 24 hours for three days (72 hours)

Enoxaparin thromboprophylaxis (40 mg) daily as continuous intravenous infusion for three days (72 hours)

Subcutaneous enoxaparin (Klexane®, Sanofi-Aventis) 0.5 mg/kg thromboprophylaxis twice a day for three days (72 hours)

Enoxaparin thromboprophylaxis 1 mg/kg daily as continuous intravenous infusion for three days (72 hours)

Outcomes

Primary Outcome Measures

Anti-Xa concentration maximum 0-24h (Cmax0-24h)
Anti-Xa concentration maximum level calculated from measured values during 0-24h after initiation of enoxaparin.

Secondary Outcome Measures

Anti-Xa concentration maximum 25-72 h (Cmax25-72h)
Anti-Xa concentration maximum level calculated from measured values 25-72h after the initiation of enoxaparin.
Anti-Xa trough concentartion at 72 h (C72h)
Anti-Xa concentration at the of 72h study period

Full Information

First Posted
June 15, 2015
Last Updated
May 5, 2023
Sponsor
Tampere University Hospital
Collaborators
Heart Hospital, Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02474212
Brief Title
: Pharmacokinetics of Enoxaparin After Coronary Artery Bypass Graft Surgery
Official Title
Anti-Xa Concentrations With Continuous Intravenous Infusion and Subcutaneous Administration of Enoxaparin After Coronary Artery Bypass Grafting: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampere University Hospital
Collaborators
Heart Hospital, Tampere University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Pulmonary Embolism, Thromboprophylaxis
Keywords
Venous thromboembolism, pulmonary embolism, thromboprophylaxis, anticoagulant, anti-FXa, low-molecular weight heparin, enoxaparin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enoxaparin 40 mg s.c.
Arm Type
Active Comparator
Arm Description
Subcutaneous enoxaparin (Klexane®, Sanofi-Aventis) 40 mg thromboprophylaxis every 24 hours for three days (72 hours)
Arm Title
Enoxaparin 40 mg i.v.
Arm Type
Active Comparator
Arm Description
Enoxaparin thromboprophylaxis (40 mg) daily as continuous intravenous infusion for three days (72 hours)
Arm Title
Enoxaparin 0.5 mg/kg s.c.
Arm Type
Active Comparator
Arm Description
Subcutaneous enoxaparin (Klexane®, Sanofi-Aventis) 0.5 mg/kg thromboprophylaxis twice a day for three days (72 hours)
Arm Title
Enoxaparin 1 mg/kg i.v.
Arm Type
Active Comparator
Arm Description
Enoxaparin thromboprophylaxis 1 mg/kg daily as continuous intravenous infusion for three days (72 hours)
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Primary Outcome Measure Information:
Title
Anti-Xa concentration maximum 0-24h (Cmax0-24h)
Description
Anti-Xa concentration maximum level calculated from measured values during 0-24h after initiation of enoxaparin.
Time Frame
0-24h after initiation of enoxaparin
Secondary Outcome Measure Information:
Title
Anti-Xa concentration maximum 25-72 h (Cmax25-72h)
Description
Anti-Xa concentration maximum level calculated from measured values 25-72h after the initiation of enoxaparin.
Time Frame
25-72 h after initiation of enoxaparin
Title
Anti-Xa trough concentartion at 72 h (C72h)
Description
Anti-Xa concentration at the of 72h study period
Time Frame
72 h after the initiation of enoxaparin
Other Pre-specified Outcome Measures:
Title
Clinical outcomes
Description
Postoperative bleeding, DVT, pulmonary embolism, 90 day mortality
Time Frame
0-90 days after initiation of enoxaparin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33521
Country
Finland

12. IPD Sharing Statement

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: Pharmacokinetics of Enoxaparin After Coronary Artery Bypass Graft Surgery

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