Venous ThromboembolismPhase 3FiXETNCT02486666
Pilot Feasibility and Safety of Administering Weight Adjusted Fixed LMWH Dose
A Phase 3 study testing Enoxaparin in people with Venous Thromboembolism, run by Hamilton Health Sciences Corporation at 4 sites in 2 countries.
Trial summary
Background Enoxaparin is a commonly used low molecular weight heparin (LMWH) for the treatment of neonatal and children thrombosis that is monitored with anti-factor Xa (anti-Xa) levels. However, this therapeutic range of anti-Xa (0.5 - 1.0 u/ml) was extrapolated from adult studies. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Enoxaparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Mar 2016to Dec 2022
- Phase
- Phase 3
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Birth to under 18 years of age at the diagnosis of thrombosis event
- Diagnosis of deep vein thrombosis confirmed by either venography or ultrasound, pulmonary embolism confirmed by ventilation perfusion scan or spiral CT scan or pulmonary angiogram, clinically stable cerebral sinovenous thrombosis confirmed with magnetic resonance imaging, or cardiac thrombosis diagnosed by echocardiogram.
- The treating team has decided to initiate anti-coagulation therapy
Who cannot join
- Platelet count < 50x109/L;
- Hemorrhage or high risk of bleeding with the use of anticoagulation therapy;
- Creatinine > 1.5x upper limit of normal;
- Liver dysfunction associated with coagulopathy leading to a clinically relevant bleeding risk;
- Documented history of heparin induced thrombocytopenia;
- Known contraindication to heparin
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Canada3 sites, 3 recruiting
- Recruiting
IWK Health Center
Halifax, Nova Scotia, B3K 6R8
Zara Forbrigger, zara.forbrigger@iwk.nshealth.ca
Ketan Kulkarni, MD
- Recruiting
HHSC/McMaster Children's Hospital
Hamilton, Ontario, L8N3Z5
Wenli Xie, MSc, 905-521-2100 ext. 76054, xiew@mcmaster.ca
Mihir Bhatt, MD
- Not yet recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Tracy Jackson, CCRP, (613) 737-7600 ext. 3101, TJackson@cheo.on.ca
Ewurabena Simpson, MD
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Isabella Mccary, 215-590-0431 ext. 40431, MCCARYI@email.chop.edu
Leslie Raffini, MD
About this study
Official title: A Pilot Feasibility And Safety Multicenter Trial Of Administering Weight Adjusted Fixed Dose Of Low Molecular Weight Heparin (Enoxaparin) To Neonates and Children With Thrombosis (FiXET)
Background Enoxaparin is a commonly used low molecular weight heparin (LMWH) for the treatment of neonatal and children thrombosis that is monitored with anti-factor Xa (anti-Xa) levels. However, this therapeutic range of anti-Xa (0.5 - 1.0 u/ml) was extrapolated from adult studies. The burden of pain to neonates due to venipunctures and of resources to the health care system also warrants an evidence-based review to assess the utility of monitoring LMWH therapy with anti-Xa levels.
Methods/Design This is a prospective pilot, feasibility and safety multicenter, randomized controlled trial to compare the approach of treating thrombosis in neonates and children with enoxaparin using weight adjusted fixed dose to variable dose titrated to maintain a pre-determined anti-Xa range (0.5-1.0 u/mL). We plan to recruit 20 neonates and children over the study period, who will be randomized within their first week of anti-coagulation treatment. Key feasibility outcomes include screening/recruitment ratio, monthly recruitment rate, and completeness of data collection. We will also measure the safety outcome of bleeding as well as comment on efficacy of resolution of thrombosis as a secondary outcome.
Discussion The administration of weight adjusted fixed dose of enoxaparin without anti-Xa monitoring has the potential to reduce pain from multiple venipunctures in neonates and children as well as resources used in their already complex care. The results of the FiXET trial will set the framework for a larger multicenter randomized controlled trial to compare the efficacy of administering enoxaparin to neonates and children without monitoring to the current conventional approach of routine monitoring with anti-Xa levels.
Read the detailed description
- Scientific Rationale Enoxaparin is a commonly used low molecular weight heparin (LMWH) for the treatment of neonatal and children thrombosis that is monitored with anti-factor Xa (anti-Xa) levels. However, this therapeutic range of anti-Xa (0.5 - 1.0 u/ml) was extrapolated from adult studies. The burden of pain to neonates and children due to venipunctures and of resources to the health care system also warrants an evidence-based review to assess the utility of monitoring LMWH therapy with anti-Xa levels. This FiXET trial is to compare the approach of treating thrombosis in neonates and children with enoxaparin using weight adjusted fixed dose to variable dose titrated to maintain a pre-determined anti-Xa range (0.5-1.0 u/mL). We plan to recruit 20 neonates and children over the study period, who will be randomized within their first week of anti-coagulation treatment. Key feasibility outcomes include screening/recruitment ratio, monthly recruitment rate, and completeness of data collection. We will also measure the safety outcome of bleeding as well as comment on efficacy of resolution of thrombosis as a secondary outcome. 1.1 Potential Risk and Benefits The administration of weight adjusted fixed dose of enoxaparin without anti-Xa monitoring has the potential to reduce pain from multiple venipunctures in neonates and children as well as resources used in their care. The results of the FiXET trial will provide preliminary clinical data regarding the feasibility and safety of this approach to anticoagulation treatment in neonates and children. It will also provide a preliminary idea about the efficacy of such an approach. This trial, if successful, will set groundwork for a larger multicenter randomized controlled trial to compare the efficacy of administering enoxaparin to neonates and children without monitoring to the current conventional approach of routine monitoring with anti-Xa levels.
- Study Objectives The aim of this trial is to determine the feasibility and safety of doing a randomized control trial to compare the approach of treating thrombosis in neonates and children with enoxaparin using weight adjusted fixed dose to variable dose titrated to maintain a pre-determined anti-Xa range (0.5-1.0 u/mL).
- Eligibility Criteria Four or more tertiary hospitals will participate in this trial. We plan to recruit a total of 20 patients based on the following protocol-defined inclusion and exclusion criteria.
- Study Design FiXET trial is a prospective pilot, feasibility and safety multicenter, randomized controlled trial. Recruitment will start following institutional REB approval. This will occur over 1year per centre and may take up to 2 years. Analysis and dissemination will occur after this period of time. 4.1 Study Endpoints Primary Objective The primary outcome of this trial is to assess feasibility and safety, as defined below, of administering a weight adjusted fixed dose of enoxaparin to neonates and children with thrombosis. Feasibility criteria
- At least 5 subjects can be recruited in each participating centre over the study period
- At least 50% of all approached patients can be recruited
- Complete data collection and follow-up of at least 90% of all recruited subjects Safety criteria
- No more than 20% of subjects are removed from the study due to 1) low or high anti-Xa levels, or 2) major bleeding Major bleeding will be defined as (i) fatal bleeding; (ii) clinically overt bleeding resulting associated with a decrease in hemoglobin of 20 g/L (2 g/dL) in a 24 hour period; (iii) bleeding into a critical organ (intracranial, pulmonary or retroperitoneal); or bleeding requiring surgical intervention [17]. Minor bleeding will be defined as any overt or macroscopic evidence of bleeding that does not fulfill criteria for major bleeding [17]. Secondary Objective Secondary outcome measures include 1) efficacy in resolution of thrombosis; 2) mean anti-Xa levels; 3) number of enoxaparin dose adjustments required in the control arm; and 4) number of venipuncture attempts for blood sampling in patients.
- Expected Duration of Participant Participation The duration of enoxaparin therapy will be 6 weeks to 6 months at the discretion of the treating physician.
- Conditions
- Venous Thromboembolism
- Being tested
- Enoxaparin
- Keywords
- Enoxaparin, thrombosis, neonate, children, RCT
- Medical subject headings
- Venous Thromboembolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
Also called Enoxaparin sodium
WEIGHT ADJUSTED FiXED DOSE OF LOW MOLECULAR WEIGHT HEPARIN (ENOXAPARIN) TO NEONATES AND CHILDREN WITH THROMBOSIS (FiXET)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Experimental Arm:patients will not have any dose titration regardless of anti-Xa level.
Premature neonates will receive enoxaparin 2.0 mg/kg/dose rounded to nearest whole mg twice daily, while term neonates will receive enoxaparin 1.7 mg/kg/dose rounded to nearest whole mg twice daily. Children≥1 month corrected age will receive 1.5 mg/kg/dose twice daily (maybe rounded +/- 10% for convenience of dosing) while children≥2 month corrected age will receive 1.0 mg/kg/dose twice daily (maybe rounded +/- 10% for convenience of dosing). Receives: Drug: Enoxaparin |
| Control Arm | Other | Control Arm: patients who will have dose titration based on anti-Xa levels to maintain a therapeutic range of 0.5-1.0 u/mL (standard of care). Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruiting at least 5 subjects over the study period per center
- Number of Participants from each participating center
- Rate of recruitment per approaching
- Rate of completed data collection and follow-up per all recruited subjects These variables will be combined to reflect the feasibility of trial recruitment
Measured: 12 - 24 months
Safety of administering a weight adjusted fixed dose of enoxaparin to neonates and children with thrombosis
- Percentage of subjects removed from the study due to 1) low or high anti Xa levels or 2) major bleeding
Measured: 12 - 24months
Secondary outcomes (2)
Efficacy in resolution of thrombosis
-Rate of thrombosis resolution
Measured: 12-24 months
Safety of anticoagulation
- Mean anti-Xa levels
- Number of Enoxaparin dose adjustments in the control arm
- Number of venipuncture attempts for blood sampling These Categorical variables will be combined to analyze the safety of this FiXET dose anticoagulation therapy on patients
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startMar 2016
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
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.
- 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- IWK Health Centre, Children's Hospital of Philadelphia, Children's Hospital of Eastern Ontario
- Responsible party
- Sponsor
- Investigators
- Mihir Bhatt, MD, Principal investigator, HHSC/McMaster Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486666
- Sponsor's protocol ID
- HamiltonHSC
- Acronym
- FiXET
- Status last verified
- Oct 2021
- First submitted
- 14 May 2015
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility And Safety Multicenter Trial Of Administering Weight Adjusted Fixed Dose Of Low Molecular Weight Heparin (Enoxaparin) To Neonates and Children With Thrombosis (FiXET)
- ClinicalTrials.gov ID
- NCT02486666
- Acronym / sponsor ID
- FiXET / HamiltonHSC
- Conditions
- Venous Thromboembolism
- Keywords
- Enoxaparin, thrombosis, neonate, children, RCT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- IWK Health Centre, Children's Hospital of Philadelphia, Children's Hospital of Eastern Ontario
- Study start
- Mar 2016
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Jul 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.
Background Enoxaparin is a commonly used low molecular weight heparin (LMWH) for the treatment of neonatal and children thrombosis that is monitored with anti-factor Xa (anti-Xa) levels. However, this therapeutic range of anti-Xa (0.5 - 1.0 u/ml) was extrapolated from adult studies. The burden of pain to neonates due to venipunctures and of resources to the health care system also warrants an evidence-based review to assess the utility of monitoring LMWH therapy with anti-Xa levels.
Methods/Design This is a prospective pilot, feasibility and safety multicenter, randomized controlled trial to compare the approach of treating thrombosis in neonates and children with enoxaparin using weight adjusted fixed dose to variable dose titrated to maintain a pre-determined anti-Xa range (0.5-1.0 u/mL). We plan to recruit 20 neonates and children over the study period, who will be randomized within their first week of anti-coagulation treatment. Key feasibility outcomes include screening/recruitment ratio, monthly recruitment rate, and completeness of data collection. We will also measure the safety outcome of bleeding as well as comment on efficacy of resolution of thrombosis as a secondary outcome.
Discussion The administration of weight adjusted fixed dose of enoxaparin without anti-Xa monitoring has the potential to reduce pain from multiple venipunctures in neonates and children as well as resources used in their already complex care. The results of the FiXET trial will set the framework for a larger multicenter randomized controlled trial to compare the efficacy of administering enoxaparin to neonates and children without monitoring to the current conventional approach of routine monitoring with anti-Xa levels.
Detailed description
- Scientific Rationale Enoxaparin is a commonly used low molecular weight heparin (LMWH) for the treatment of neonatal and children thrombosis that is monitored with anti-factor Xa (anti-Xa) levels. However, this therapeutic range of anti-Xa (0.5 - 1.0 u/ml) was extrapolated from adult studies. The burden of pain to neonates and children due to venipunctures and of resources to the health care system also warrants an evidence-based review to assess the utility of monitoring LMWH therapy with anti-Xa levels. This FiXET trial is to compare the approach of treating thrombosis in neonates and children with enoxaparin using weight adjusted fixed dose to variable dose titrated to maintain a pre-determined anti-Xa range (0.5-1.0 u/mL). We plan to recruit 20 neonates and children over the study period, who will be randomized within their first week of anti-coagulation treatment. Key feasibility outcomes include screening/recruitment ratio, monthly recruitment rate, and completeness of data collection. We will also measure the safety outcome of bleeding as well as comment on efficacy of resolution of thrombosis as a secondary outcome. 1.1 Potential Risk and Benefits The administration of weight adjusted fixed dose of enoxaparin without anti-Xa monitoring has the potential to reduce pain from multiple venipunctures in neonates and children as well as resources used in their care. The results of the FiXET trial will provide preliminary clinical data regarding the feasibility and safety of this approach to anticoagulation treatment in neonates and children. It will also provide a preliminary idea about the efficacy of such an approach. This trial, if successful, will set groundwork for a larger multicenter randomized controlled trial to compare the efficacy of administering enoxaparin to neonates and children without monitoring to the current conventional approach of routine monitoring with anti-Xa levels.
- Study Objectives The aim of this trial is to determine the feasibility and safety of doing a randomized control trial to compare the approach of treating thrombosis in neonates and children with enoxaparin using weight adjusted fixed dose to variable dose titrated to maintain a pre-determined anti-Xa range (0.5-1.0 u/mL).
- Eligibility Criteria Four or more tertiary hospitals will participate in this trial. We plan to recruit a total of 20 patients based on the following protocol-defined inclusion and exclusion criteria.
- Study Design FiXET trial is a prospective pilot, feasibility and safety multicenter, randomized controlled trial. Recruitment will start following institutional REB approval. This will occur over 1year per centre and may take up to 2 years. Analysis and dissemination will occur after this period of time. 4.1 Study Endpoints Primary Objective The primary outcome of this trial is to assess feasibility and safety, as defined below, of administering a weight adjusted fixed dose of enoxaparin to neonates and children with thrombosis. Feasibility criteria
- At least 5 subjects can be recruited in each participating centre over the study period
- At least 50% of all approached patients can be recruited
- Complete data collection and follow-up of at least 90% of all recruited subjects Safety criteria
- No more than 20% of subjects are removed from the study due to 1) low or high anti-Xa levels, or 2) major bleeding Major bleeding will be defined as (i) fatal bleeding; (ii) clinically overt bleeding resulting associated with a decrease in hemoglobin of 20 g/L (2 g/dL) in a 24 hour period; (iii) bleeding into a critical organ (intracranial, pulmonary or retroperitoneal); or bleeding requiring surgical intervention [17]. Minor bleeding will be defined as any overt or macroscopic evidence of bleeding that does not fulfill criteria for major bleeding [17]. Secondary Objective Secondary outcome measures include 1) efficacy in resolution of thrombosis; 2) mean anti-Xa levels; 3) number of enoxaparin dose adjustments required in the control arm; and 4) number of venipuncture attempts for blood sampling in patients.
- Expected Duration of Participant Participation The duration of enoxaparin therapy will be 6 weeks to 6 months at the discretion of the treating physician.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: EnoxaparinExperimental Arm:patients will not have any dose titration regardless of anti-Xa level. Premature neonates will receive enoxaparin 2.0 mg/kg/dose rounded to nearest whole mg twice daily, while term neonates will receive enoxaparin 1.7 mg/kg/dose rounded to nearest whole mg twice daily. Children≥1 month corrected age will receive 1.5 mg/kg/dose twice daily (maybe rounded +/- 10% for convenience of dosing) while children≥2 month corrected age will receive 1.0 mg/kg/dose twice daily (maybe rounded +/- 10% for convenience of dosing). |
| Control Arm | Other | Drug: EnoxaparinControl Arm: patients who will have dose titration based on anti-Xa levels to maintain a therapeutic range of 0.5-1.0 u/mL (standard of care). |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Birth to under 18 years of age at the diagnosis of thrombosis event
- Diagnosis of deep vein thrombosis confirmed by either venography or ultrasound, pulmonary embolism confirmed by ventilation perfusion scan or spiral CT scan or pulmonary angiogram, clinically stable cerebral sinovenous thrombosis confirmed with magnetic resonance imaging, or cardiac thrombosis diagnosed by echocardiogram.
- The treating team has decided to initiate anti-coagulation therapy
Key exclusion criteria (6 listed)
- Platelet count < 50x109/L;
- Hemorrhage or high risk of bleeding with the use of anticoagulation therapy;
- Creatinine > 1.5x upper limit of normal;
- Liver dysfunction associated with coagulopathy leading to a clinically relevant bleeding risk;
- Documented history of heparin induced thrombocytopenia;
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: Enoxaparin sodiumWEIGHT ADJUSTED FiXED DOSE OF LOW MOLECULAR WEIGHT HEPARIN (ENOXAPARIN) TO NEONATES AND CHILDREN WITH THROMBOSIS (FiXET) | Drug | Control Arm, Experimental Arm |
Primary outcome
Feasibility of recruiting at least 5 subjects over the study period per center
Time frame: 12 - 24 months
* Number of Participants from each participating center * Rate of recruitment per approaching * Rate of completed data collection and follow-up per all recruited subjects These variables will be combined to reflect the feasibility of trial recruitment
Safety of administering a weight adjusted fixed dose of enoxaparin to neonates and children with thrombosis
Time frame: 12 - 24months
- Percentage of subjects removed from the study due to 1) low or high anti Xa levels or 2) major bleeding
2 secondary outcomes
Efficacy in resolution of thrombosis
Time frame: 12-24 months
Safety of anticoagulation
Time frame: 12-24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Mihir Bhatt, MD principal investigator
HHSC/McMaster Children's Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enoxaparin in people with Venous Thromboembolism, run by Hamilton Health Sciences Corporation at 4 sites in 2 countries.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenli Xie, MSc, CCRC (905-521-2100 ext. 76054, xiew@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruiting at least 5 subjects over the study period per center (time frame: 12 - 24 months). The study lists 2 primary outcomes in all. 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 15 Oct 2021.