Venous ThromboembolismPhase 4NCT02095509
Pharmacokinetics of Enoxaparin in Intensive Care Patients
A Phase 4 study testing Enoxaparin in people with Venous Thromboembolism, run by Tampere University Hospital at 2 sites in Finland.
Trial summary
To evaluate the pharmacokinetics of the thromboprophylactic agent enoxaparin in critically ill patients by comparing plasma anti-factor Xa activity when enoxaparin is administered either as a continuous intravenous infusion or subcutaneous bolus once daily. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Venous Thromboembolism
- 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
- 39 participants
- Where
- 2 sitesFinland
- Study dates
- Mar 2014to 30 Sep 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index between 18-30 kg/m2
- Critically ill patients requiring intensive care and pharmacological thromboprophylaxis
- Expected to remain in the ICU for at least 72 h
- Written informed consent obtained from the patient or his/her legal representative.
Who cannot join
- Other indications for anticoagulant therapy than thromboprophylaxis
- Intracranial haemorrhage or central neurosurgical operation within three months prior to the admission
- Disseminated intravascular coagulation (DIC) according to the international society on Thrombosis and Haemostasis criteria
- Known heparin induced thrombocytopenia (HIT), or hypersensitivity to enoxaparin or heparin
- Treatment with enoxaparin or any other low-molecular weight heparin (LMWH) or heparin within 24 hours prior to ICU admission. If patient has received thromboprophylactic dose of LMWH within 24-72 hours before ICU admission inclusion can be done if measured anti-factor Xa level is <0.1 IU/ml at the time of admission
- Any long-term anticoagulant medication, expect low-dose aspirin
Show all 11Show fewer
- Major bleeding within the last week unless definitively treated
- Blood platelet count <50, P-thromboplastin time (TT) <40% , international normalized ratio (INR) >1.7
- Glomerular filtration rate less than 50 ml/min/1.73 m2 estimated from serum creatinine by applying Cockcroft-Gault equation or chronic dialysis
- HIV, hepatitis B virus, or hepatitis C virus infection
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Helsinki University Central Hospital, Meilahti
Helsinki, Uusimaa, 00029
Tampere University Hospital
Tampere, Pirkanmaa, 33521
About this study
Official title: Plasma Anti-FXa Concentration After Continuous Intravenous Infusion and Subcutaneous Dosing of Enoxaparin for Thromboprophylaxis in Critically Ill Patients
To evaluate the pharmacokinetics of the thromboprophylactic agent enoxaparin in critically ill patients by comparing plasma anti-factor Xa activity when enoxaparin is administered either as a continuous intravenous infusion or subcutaneous bolus once daily.
To investigate possible ongoing coagulation by coagulation markers during antithrombotic therapy with standard doses of enoxaparin
- Conditions
- Venous Thromboembolism
- Being tested
- Enoxaparin
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
Also called Klexane (sanofi-Aventis Oy, Finland)
Drug class: Low-molecular weight heparin
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous Enoxaparin | Active comparator | Subcutaneous enoxaparin 40 mg every 24 hours for three days Receives: Drug: Enoxaparin |
| Intravenous Enoxaparin | Active comparator | 40 mg enoxaparin 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.
Plasma anti-factor Xa level
Change in plasma anti-factor Xa levels between baseline and 72 hours
Measured: 72 hours
Secondary outcomes (2)
Incidence of Venous thromboembolism
If clinically suspected a compression ultrasound will be done
Measured: 90 days
Incidence of Bleeding
Major and minor bleeding events will be reported
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startMar 2014
- Primary completion30 Jun 2016
- Study completion30 Sep 2016
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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095509
- Sponsor's protocol ID
- 2012-004599-21
- Status last verified
- Oct 2017
- First submitted
- 18 Mar 2014
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Anti-FXa Concentration After Continuous Intravenous Infusion and Subcutaneous Dosing of Enoxaparin for Thromboprophylaxis in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02095509
- Acronym / sponsor ID
- 2012-004599-21
- Conditions
- Venous Thromboembolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital
- Study start
- Mar 2014
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 24 Mar 2014 (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 the thromboprophylactic agent enoxaparin in critically ill patients by comparing plasma anti-factor Xa activity when enoxaparin is administered either as a continuous intravenous infusion or subcutaneous bolus once daily.
To investigate possible ongoing coagulation by coagulation markers during antithrombotic therapy with standard doses of enoxaparin
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous Enoxaparin | Active comparator | Drug: EnoxaparinSubcutaneous enoxaparin 40 mg every 24 hours for three days |
| Intravenous Enoxaparin | Active comparator | Drug: Enoxaparin40 mg enoxaparin daily as continuous intravenous infusion for three days (72 hours) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body Mass Index between 18-30 kg/m2
- Critically ill patients requiring intensive care and pharmacological thromboprophylaxis
- Expected to remain in the ICU for at least 72 h
- Written informed consent obtained from the patient or his/her legal representative.
Key exclusion criteria (11 listed)
- Other indications for anticoagulant therapy than thromboprophylaxis
- Intracranial haemorrhage or central neurosurgical operation within three months prior to the admission
- Disseminated intravascular coagulation (DIC) according to the international society on Thrombosis and Haemostasis criteria
- Known heparin induced thrombocytopenia (HIT), or hypersensitivity to enoxaparin or heparin
- Treatment with enoxaparin or any other low-molecular weight heparin (LMWH) or heparin within 24 hours prior to ICU admission. If patient has received thromboprophylactic dose of LMWH within 24-72 hours before ICU admission inclusion can be done if measured anti-factor Xa level is <0.1 IU/ml at the time of admission
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 |
|---|---|---|
| EnoxaparinAlso: Klexane (sanofi-Aventis Oy, Finland)Drug class: Low-molecular weight heparin | Drug | Intravenous Enoxaparin, Subcutaneous Enoxaparin |
Primary outcome
Plasma anti-factor Xa level
Time frame: 72 hours
Change in plasma anti-factor Xa levels between baseline and 72 hours
2 secondary outcomes
Incidence of Venous thromboembolism
Time frame: 90 days
Incidence of Bleeding
Time frame: 90 days
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 27 Oct 2017.
Related trials for Venous Thromboembolism
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
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.
2 sites 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, run by Tampere University Hospital at 2 sites 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 11 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 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Plasma anti-factor Xa level (time frame: 72 hours). 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 27 Oct 2017.