Venous ThromboembolismPhase 4NCT02474212
: Pharmacokinetics of Enoxaparin After Coronary Artery Bypass Graft Surgery
A Phase 4 study testing Enoxaparin in people with Venous Thromboembolism and Pulmonary Embolism, run by Tampere University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Venous Thromboembolism, Pulmonary Embolism, Thromboprophylaxis
- What is being tested?
- Enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteFinland
- Study dates
- May 2016to 31 Mar 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-Xa Concentrations With Continuous Intravenous Infusion and Subcutaneous Administration of Enoxaparin After Coronary Artery Bypass Grafting: Randomized Clinical Trial
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.
Read the 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.
- Being tested
- Enoxaparin
- Keywords
- Venous thromboembolism, pulmonary embolism, thromboprophylaxis, anticoagulant, anti-FXa, low-molecular weight heparin, enoxaparin
- Medical subject headings
- Venous Thromboembolism, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin 40 mg s.c. | Active comparator | Subcutaneous enoxaparin (Klexane®, Sanofi-Aventis) 40 mg thromboprophylaxis every 24 hours for three days (72 hours) Receives: Drug: Enoxaparin |
| Enoxaparin 40 mg i.v. | Active comparator | Enoxaparin thromboprophylaxis (40 mg) daily as continuous intravenous infusion for three days (72 hours) Receives: Drug: Enoxaparin |
| Enoxaparin 0.5 mg/kg s.c. | Active comparator | Subcutaneous enoxaparin (Klexane®, Sanofi-Aventis) 0.5 mg/kg thromboprophylaxis twice a day for three days (72 hours) Receives: Drug: Enoxaparin |
| Enoxaparin 1 mg/kg i.v. | Active comparator | Enoxaparin thromboprophylaxis 1 mg/kg daily as continuous intravenous infusion for three days (72 hours) Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Xa concentration maximum 0-24h (Cmax0-24h)
Anti-Xa concentration maximum level calculated from measured values during 0-24h after initiation of enoxaparin.
Measured: 0-24h after initiation of enoxaparin
Secondary outcomes (2)
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.
Measured: 25-72 h after initiation of enoxaparin
Anti-Xa trough concentartion at 72 h (C72h)
Anti-Xa concentration at the of 72h study period
Measured: 72 h after the initiation of enoxaparin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startMay 2016
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere Heart Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474212
- Sponsor's protocol ID
- 290115-1
- Status last verified
- May 2023
- First submitted
- 15 Jun 2015
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Xa Concentrations With Continuous Intravenous Infusion and Subcutaneous Administration of Enoxaparin After Coronary Artery Bypass Grafting: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02474212
- Acronym / sponsor ID
- 290115-1
- Keywords
- Venous thromboembolism, pulmonary embolism, thromboprophylaxis, anticoagulant, anti-FXa, low-molecular weight heparin, enoxaparin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere Heart Hospital
- Study start
- May 2016 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 17 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin 40 mg s.c. | Active comparator | Drug: EnoxaparinSubcutaneous enoxaparin (Klexane®, Sanofi-Aventis) 40 mg thromboprophylaxis every 24 hours for three days (72 hours) |
| Enoxaparin 40 mg i.v. | Active comparator | Drug: EnoxaparinEnoxaparin thromboprophylaxis (40 mg) daily as continuous intravenous infusion for three days (72 hours) |
| Enoxaparin 0.5 mg/kg s.c. | Active comparator | Drug: EnoxaparinSubcutaneous enoxaparin (Klexane®, Sanofi-Aventis) 0.5 mg/kg thromboprophylaxis twice a day for three days (72 hours) |
| Enoxaparin 1 mg/kg i.v. | Active comparator | Drug: EnoxaparinEnoxaparin thromboprophylaxis 1 mg/kg daily as continuous intravenous infusion for three days (72 hours) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparin | Drug | Enoxaparin 0.5 mg/kg s.c., Enoxaparin 1 mg/kg i.v., Enoxaparin 40 mg i.v., Enoxaparin 40 mg s.c. |
Primary outcome
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.
2 secondary outcomes
Anti-Xa concentration maximum 25-72 h (Cmax25-72h)
Time frame: 25-72 h after initiation of enoxaparin
Anti-Xa trough concentartion at 72 h (C72h)
Time frame: 72 h after the initiation of enoxaparin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enoxaparin in people with Venous Thromboembolism and Pulmonary Embolism, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Xa concentration maximum 0-24h (Cmax0-24h) (time frame: 0-24h after initiation of enoxaparin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.