Deep Venous ThrombosisPhase 2CRETENCT03003390
Catheter-Related Early Thromboprophylaxis With Enoxaparin (CRETE) Trial
A Phase 2 study testing Enoxaparin in people with Deep Venous Thrombosis, run by Yale University at 6 sites in United States.
Trial summary
The purpose of this phase 2a, multi-center, randomized controlled study, is to explore the efficacy of early prophylaxis against catheter-associated deep venous thrombosis (CADVT) in critically ill children. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Deep Venous Thrombosis
- 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
- 51 participants
- Where
- 6 sitesUnited States
- Study dates
- 5 Apr 2017to 16 Aug 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Untunneled CVC inserted in the internal jugular or femoral vein within the past 24 hours
- Child anticipated to stay in the pediatric intensive care unit ≥48 hours
- CVC anticipated to be required for ≥24 hours
- >36 weeks corrected gestational age to <18 years old
Who cannot join
- Coagulopathy (i.e., international normalized ratio >2.0, activated partial thromboplastin time >50 seconds or platelet count <50,000/mm3)
- Known bleeding disorder
- Clinically relevant bleeding as defined by the International Society on Thrombosis and Hemostasis (i.e., Hb decreased ≥2 g/dl in 24 hours, required medical or surgical intervention to restore hemostasis, or in a critical organ system [i.e., retroperitoneum, pulmonary, intracranial or central nervous system])
- <60 days from a clinically relevant bleeding as defined above
- <7 days after trauma or surgery
- Anticipated surgery within 48 hours after insertion of the CVC
Show all 16Show fewer
- Renal failure (i.e., creatinine clearance <30 mL/min)
- Presence of epidural catheter
- Currently taking an antithrombotic agent (e.g., low molecular weight heparin (LMWH), unfractionated heparin (UFH) at therapeutic doses, Coumadin or aspirin)
- Radiologically documented DVT at the site of insertion of the CVC in the previous 6 weeks
- Known hypersensitivity to heparin or its components, including pork products
- History of heparin-induced thrombocytopenia (HIT) (i.e., positive serotonin release assay)
- Currently pregnant
- Currently lactating
- Prior enrollment in the study
- Limitation of care
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Children's Hospital of Wisconsin/Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Yale University Yale New Haven Health
New Haven, Connecticut, 06520
Weill Cornell Medicine
New York, New York, 10065
University of Rochester Medical Center-Golisano Children's Hospital-
Rochester, New York, 14642
Saint Louis Children's Hospital-Washington University School of Medicine-
St Louis, Missouri, 63110
Maria Fareri Children's Hospital
Valhalla, New York, 10595
About this study
Official title: Prevention of Central Venous Catheter-associated Thrombosis in Critically Ill Children: A Multicenter Phase 2b Trial
The purpose of this phase 2a, multi-center, randomized controlled study, is to explore the efficacy of early prophylaxis against catheter-associated deep venous thrombosis (CADVT) in critically ill children.
Read the detailed description
Critical illness and the presence of a central venous catheter (CVC) are the most important risk factors for deep venous thrombosis (DVT) in children. Catheter-associated thrombosis (CADVT) is highly prevalent and associated with poor outcomes in critically ill children. Yet, based on underpowered pediatric trials, prophylaxis against CADVT is not recommended in children. The recommendation to provide prophylaxis against thrombosis in critically ill adults should not be applied to children because the hemostatic system and co-morbidities vastly differ between age groups. Pivotal trials are urgently needed to determine whether prophylaxis can prevent CADVT and its complications in critically ill children. However, the timing and extent of reduction in thrombin generation, the biochemical goal of prophylaxis, needed to prevent CADVT in children are unclear. The goal of this application is to explore the efficacy of early prophylaxis against CADVT in critically ill children. Aim 1 is to obtain preliminary evidence on the effect of early prophylaxis on the incidence of CADVT in critically ill children. Based on the natural history of CADVT, we hypothesize that among critically ill children, prophylaxis administered <24 hours after catheter insertion decreases the incidence of ultrasound-diagnosed CADVT compared with no prophylaxis. In this phase 2a trial, children admitted to the intensive care unit with a newly inserted central venous catheter will receive enoxaparin adjusted according to anti-Xa activity, a control group will not receive enoxaparin adjusted according to anti-Xa activity. Enoxaparin has become the "standard" pediatric anticoagulant for prophylaxis despite the absence of conclusive data. We will use Bayesian approach to determine whether further trials are warranted. Aim 2 is to evaluate the effect of an anti-Xa activity-directed prophylactic strategy on thrombin generation in critically ill children. We hypothesize that among critically ill children, standard prophylactic dose of enoxaparin adjusted by anti-Xa activity reduces thrombin generation to <700 nanomolar-minute (nM.min), as measured by endogenous thrombin potential (ETP). In non-critically ill adults, prophylactic dose of enoxaparin proven to prevent DVT reduces ETP to <700 nM.min. Endogenous thrombin potential is the best available measure of thrombin generation. We will measure endogenous thrombin potential and anti-Xa activity at multiple time points then examine their relationship in all children enrolled in the phase 2a trial. The proposed research challenges the current paradigm on prophylaxis against CADVT in children. High quality evidence is needed to prevent CADVT and its complications in this vulnerable population.
- Conditions
- Deep Venous Thrombosis
- Being tested
- Enoxaparin
- Keywords
- child, critical illness, venous thromboembolism, enoxaparin, thrombin generation
- Medical subject headings
- Venous Thrombosis, Critical Illness, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
Also called Lovenox
The clinical nurse will give enoxaparin subcutaneously every 12 hours at the currently used starting dose of 0.75 mg/kg for children ≤2 months old or 0.5 mg/kg (maximum of 40 mg) for older children. The 1st dose will be given <24 hours after insertion of the catheter. Doses will be adjusted to target an anti-Xa level of 0.2-0.5 IU/mL.
| Study group | Role | What they receive |
|---|---|---|
| Prophylaxis with enoxaparin | Experimental | A clinical nurse will administer enoxaparin subcutaneously <24 hours after insertion of the central venous catheter and then give enoxaparin subcutaneously every 12 hours until the removal of the catheter. Receives: Drug: Enoxaparin |
| Control arm | No intervention | Participants randomized to the control arm will receive no 'placebo' intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Central Venous Catheter (CVC)- Associated Deep Vein Thrombosis (DVT)
Thrombus in the central vein where the CVC was inserted that is clinically suspected then confirmed radiologically, an incidental radiologic finding, or diagnosed with the study-related active surveillance ultrasound
Measured: Up to removal of CVC, an average of 6 days
Endogenous Thrombin Potential
An established measure of coagulation status and is the best method to measure thrombin generation. It directly measures the amount of thrombin generation over time capturing the effects of natural (i.e., subject's coagulation status) and pharmacological (e.g., enoxaparin) pro- and anticoagulants. Endogenous thrombin potential is measured using thrombin generation assay.
Measured: Day of, day after and day 4 after insertion of the CVC
Secondary outcomes (11)
Number With Other Thromboembolic Events
Thrombus in the deep vein of any extremity or PE that is clinically suspected then confirmed radiologically, an incidental radiologic finding, excluding DVT diagnosed with the study-related active surveillance ultrasound
Measured: Up to removal of CVC, an average of 6 days
Length of Stay in the Pediatric Intensive Care Unit in Days
Duration of stay in the pediatric intensive care unit from the day of enrollment
Measured: Up to day of discharge from the pediatric intensive care unit, an average of 10 days
Length of Stay in the Hospital
Duration of stay in the hospital from the day of enrollment
Measured: Up to day of discharge from the hospital, an average of 18 days
Number With Clinically Relevant Bleeding
Bleeding that is fatal, associated with a decrease in hemoglobin by ≥2 g/dl in 24 hours, requires medical or surgical intervention to restore hemostasis, or is in the retroperitoneum, pulmonary, intracranial or central nervous system as defined by International Society of Thrombosis and Haemostasis
Measured: Up to 30 hours after the last enoxaparin dose
Number With Laboratory Confirmed Heparin-induced Thrombocytopenia
Heparin-induced thrombocytopenia that is diagnosed with a positive serotonin release assay
Measured: Up to removal of CVC, an average of 6 days
Number of Mortality
In-hospital mortality during the subject's admission
Measured: Up to day of discharge from the hospital, average of 18 days
Number of Enrolled Eligible Children
Number of eligible children enrolled in the study.
Measured: Up to 24 hours after insertion of CVC
Time to 1st Dose of Enoxaparin
Time to first dose of enoxaparin
Measured: Up to 48 hours after insertion of CVC
Time to Target Anti-Xa Activity
Time from insertion of the CVC to time that anti-Xa activity was within 0.2-0.5 IU/mL.
Measured: Up to removal of CVC, an average of 6 days
Number of Missed Doses of Enoxaparin
Number of doses of enoxaparin that were not administered. This outcome measure was only applicable to the enoxaparin arm.
Measured: Up to removal of CVC, an average of 6 days
Number of Children With Ultrasound
Number of children in whom ultrasound was not performed.
Measured: Up to 24 hours after removal of CVC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study start5 Apr 2017
- Primary completion16 Aug 2019
- Study completion16 Aug 2019
Why it stopped: Met protocol defined stopping rule for futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Deep Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible subjects will be randomized 1:1 to treatment or control.
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Louis Children's Hospital, Dell Children's Medical Center of Central Texas, Children's Hospital and Health System Foundation, Wisconsin, Weill Medical College of Cornell University, Maria Fareri Children's Hospital, University of Rochester, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- E. Vincent S Faustino, MD, MHS, Principal investigator, Associate Professor of Pediatrics, Yale School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003390
- Sponsor's protocol ID
- 1302011506
- Other IDs
- 1R21HD089131-01A1
- Acronym
- CRETE
- Status last verified
- Mar 2020
- First submitted
- 19 Dec 2016
- Last updated
- 13 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Faustino EVS, Raffini LJ, Hanson SJ, Cholette JM, Pinto MG, Li S, Kandil SB, Nellis ME, Shabanova V, Silva CT, Tala JA, McPartland T, Spinella PC; for the CRETE Trial Investigators and the Pediatric Critical Care Blood Research Network (BloodNet) of the Pediatric Acute Lung Injury and Sepsis Investigators Network (PALISI); CRETE Trial Investigators: Clinical Coordinating Center:; and; Data Coordinating Center:; and; Outcomes Adjudication Committee:; and; Data and Safety Monitoring Board:; and; Independent Safety Monitor:; and; Children's Hospital Wisconsin:; and; Dell Children's Medical Center:; and; Maria Fareri Children's Hospital:; and; St. Louis Children's Hospital:; and; University of Rochester Golisano Children's Hospital:; and; Weill Cornell Medical Center:; and; and Yale-New Haven Children's Hospital:; and; for the CRETE Trial Investigators and the Pediatric Critical Care Blood Research Network (BloodNet) of the Pediatric Acute Lung Injury and Sepsis Investigators Network (PALISI) and CRETE Trial Investigators: Clinical Coordinating Center: and and and Data Coordinating Center: and and and Outcomes Adjudication Committee: and and and Data and Safety Monitoring Board: and and and Independent Safety Monitor: and and and Children's Hospital Wisconsin: and and and Dell Children's Medical Center: and and and Maria Fareri Children's Hospital: and and and St. Louis Children's Hospital: and and and University of Rochester Golisano Children's Hospital: and and and Weill Cornell Medical Center: and and and and Yale-New Haven Children's Hospital: and and. Age-Dependent Heterogeneity in the Efficacy of Prophylaxis With Enoxaparin Against Catheter-Associated Thrombosis in Critically Ill Children: A Post Hoc Analysis of a Bayesian Phase 2b Randomized Clinical Trial. Crit Care Med. 2021 Apr 1;49(4):e369-e380. doi: 10.1097/CCM.0000000000004848.
PubMed 33566465Faustino EVS, Shabanova V, Raffini LJ, Kandil SB, Li S, Pinto MG, Cholette JM, Hanson SJ, Nellis ME, Silva CT, Chima R, Sharathkumar A, Thomas KA, McPartland T, Tala JA, Spinella PC; CRETE Trial Investigators and the Pediatric Critical Care Blood Research Network (BloodNet) of the Pediatric Acute Lung Injury and Sepsis Investigators Network (PALISI). Efficacy of Early Prophylaxis Against Catheter-Associated Thrombosis in Critically Ill Children: A Bayesian Phase 2b Randomized Clinical Trial. Crit Care Med. 2021 Mar 1;49(3):e235-e246. doi: 10.1097/CCM.0000000000004784.
PubMed 33372745
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Central Venous Catheter-associated Thrombosis in Critically Ill Children: A Multicenter Phase 2b Trial
- ClinicalTrials.gov ID
- NCT03003390
- Acronym / sponsor ID
- CRETE / 1302011506
- Conditions
- Deep Venous Thrombosis
- Keywords
- child, critical illness, venous thromboembolism, enoxaparin, thrombin generation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Met protocol defined stopping rule for futility
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- St. Louis Children's Hospital, Dell Children's Medical Center of Central Texas, Children's Hospital and Health System Foundation, Wisconsin, Weill Medical College of Cornell University, Maria Fareri Children's Hospital, University of Rochester, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 16 Aug 2019 (actual)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Posted 13 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this phase 2a, multi-center, randomized controlled study, is to explore the efficacy of early prophylaxis against catheter-associated deep venous thrombosis (CADVT) in critically ill children.
Detailed description
Critical illness and the presence of a central venous catheter (CVC) are the most important risk factors for deep venous thrombosis (DVT) in children. Catheter-associated thrombosis (CADVT) is highly prevalent and associated with poor outcomes in critically ill children. Yet, based on underpowered pediatric trials, prophylaxis against CADVT is not recommended in children. The recommendation to provide prophylaxis against thrombosis in critically ill adults should not be applied to children because the hemostatic system and co-morbidities vastly differ between age groups. Pivotal trials are urgently needed to determine whether prophylaxis can prevent CADVT and its complications in critically ill children. However, the timing and extent of reduction in thrombin generation, the biochemical goal of prophylaxis, needed to prevent CADVT in children are unclear. The goal of this application is to explore the efficacy of early prophylaxis against CADVT in critically ill children. Aim 1 is to obtain preliminary evidence on the effect of early prophylaxis on the incidence of CADVT in critically ill children. Based on the natural history of CADVT, we hypothesize that among critically ill children, prophylaxis administered <24 hours after catheter insertion decreases the incidence of ultrasound-diagnosed CADVT compared with no prophylaxis. In this phase 2a trial, children admitted to the intensive care unit with a newly inserted central venous catheter will receive enoxaparin adjusted according to anti-Xa activity, a control group will not receive enoxaparin adjusted according to anti-Xa activity. Enoxaparin has become the "standard" pediatric anticoagulant for prophylaxis despite the absence of conclusive data. We will use Bayesian approach to determine whether further trials are warranted. Aim 2 is to evaluate the effect of an anti-Xa activity-directed prophylactic strategy on thrombin generation in critically ill children. We hypothesize that among critically ill children, standard prophylactic dose of enoxaparin adjusted by anti-Xa activity reduces thrombin generation to <700 nanomolar-minute (nM.min), as measured by endogenous thrombin potential (ETP). In non-critically ill adults, prophylactic dose of enoxaparin proven to prevent DVT reduces ETP to <700 nM.min. Endogenous thrombin potential is the best available measure of thrombin generation. We will measure endogenous thrombin potential and anti-Xa activity at multiple time points then examine their relationship in all children enrolled in the phase 2a trial. The proposed research challenges the current paradigm on prophylaxis against CADVT in children. High quality evidence is needed to prevent CADVT and its complications in this vulnerable population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible subjects will be randomized 1:1 to treatment or control.
| Arm | Type | Receives |
|---|---|---|
| Prophylaxis with enoxaparin | Experimental | Drug: EnoxaparinA clinical nurse will administer enoxaparin subcutaneously <24 hours after insertion of the central venous catheter and then give enoxaparin subcutaneously every 12 hours until the removal of the catheter. |
| Control arm | No intervention | –Participants randomized to the control arm will receive no 'placebo' intervention. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Untunneled CVC inserted in the internal jugular or femoral vein within the past 24 hours
- Child anticipated to stay in the pediatric intensive care unit ≥48 hours
- CVC anticipated to be required for ≥24 hours
- >36 weeks corrected gestational age to <18 years old
Key exclusion criteria (16 listed)
- Coagulopathy (i.e., international normalized ratio >2.0, activated partial thromboplastin time >50 seconds or platelet count <50,000/mm3)
- Known bleeding disorder
- Clinically relevant bleeding as defined by the International Society on Thrombosis and Hemostasis (i.e., Hb decreased ≥2 g/dl in 24 hours, required medical or surgical intervention to restore hemostasis, or in a critical organ system [i.e., retroperitoneum, pulmonary, intracranial or central nervous system])
- <60 days from a clinically relevant bleeding as defined above
- <7 days after trauma or surgery
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: LovenoxThe clinical nurse will give enoxaparin subcutaneously every 12 hours at the currently used starting dose of 0.75 mg/kg for children ≤2 months old or 0.5 mg/kg (maximum of 40 mg) for older children. The 1st dose will be given <24 hours after insertion of the catheter. Doses will be adjusted to target an anti-Xa level of 0.2-0.5 IU/mL. | Drug | Prophylaxis with enoxaparin |
Primary outcome
Number of Participants With Central Venous Catheter (CVC)- Associated Deep Vein Thrombosis (DVT)
Time frame: Up to removal of CVC, an average of 6 days
Thrombus in the central vein where the CVC was inserted that is clinically suspected then confirmed radiologically, an incidental radiologic finding, or diagnosed with the study-related active surveillance ultrasound
Endogenous Thrombin Potential
Time frame: Day of, day after and day 4 after insertion of the CVC
An established measure of coagulation status and is the best method to measure thrombin generation. It directly measures the amount of thrombin generation over time capturing the effects of natural (i.e., subject's coagulation status) and pharmacological (e.g., enoxaparin) pro- and anticoagulants. Endogenous thrombin potential is measured using thrombin generation assay.
11 secondary outcomes
Number With Other Thromboembolic Events
Time frame: Up to removal of CVC, an average of 6 days
Length of Stay in the Pediatric Intensive Care Unit in Days
Time frame: Up to day of discharge from the pediatric intensive care unit, an average of 10 days
Length of Stay in the Hospital
Time frame: Up to day of discharge from the hospital, an average of 18 days
Number With Clinically Relevant Bleeding
Time frame: Up to 30 hours after the last enoxaparin dose
Number With Laboratory Confirmed Heparin-induced Thrombocytopenia
Time frame: Up to removal of CVC, an average of 6 days
Number of Mortality
Time frame: Up to day of discharge from the hospital, average of 18 days
Number of Enrolled Eligible Children
Time frame: Up to 24 hours after insertion of CVC
Time to 1st Dose of Enoxaparin
Time frame: Up to 48 hours after insertion of CVC
Time to Target Anti-Xa Activity
Time frame: Up to removal of CVC, an average of 6 days
Number of Missed Doses of Enoxaparin
Time frame: Up to removal of CVC, an average of 6 days
Number of Children With Ultrasound
Time frame: Up to 24 hours after removal of CVC
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33566465Faustino EVS, Raffini LJ, Hanson SJ, Cholette JM, Pinto MG, Li S, Kandil SB, Nellis ME, Shabanova V, Silva CT, Tala JA, McPartland T, Spinella PC; for the CRETE Trial Investigators and the Pediatric Critical Care Blood Research Network (BloodNet) of the Pediatric Acute Lung Injury and Sepsis Investigators Network (PALISI); CRETE Trial Investigators: Clinical Coordinating Center:; and; Data Coordinating Center:; and; Outcomes Adjudication Committee:; and; Data and Safety Monitoring Board:; and; Independent Safety Monitor:; and; Children's Hospital Wisconsin:; and; Dell Children's Medical Center:; and; Maria Fareri Children's Hospital:; and; St. Louis Children's Hospital:; and; University of Rochester Golisano Children's Hospital:; and; Weill Cornell Medical Center:; and; and Yale-New Haven Children's Hospital:; and; for the CRETE Trial Investigators and the Pediatric Critical Care Blood Research Network (BloodNet) of the Pediatric Acute Lung Injury and Sepsis Investigators Network (PALISI) and CRETE Trial Investigators: Clinical Coordinating Center: and and and Data Coordinating Center: and and and Outcomes Adjudication Committee: and and and Data and Safety Monitoring Board: and and and Independent Safety Monitor: and and and Children's Hospital Wisconsin: and and and Dell Children's Medical Center: and and and Maria Fareri Children's Hospital: and and and St. Louis Children's Hospital: and and and University of Rochester Golisano Children's Hospital: and and and Weill Cornell Medical Center: and and and and Yale-New Haven Children's Hospital: and and. Age-Dependent Heterogeneity in the Efficacy of Prophylaxis With Enoxaparin Against Catheter-Associated Thrombosis in Critically Ill Children: A Post Hoc Analysis of a Bayesian Phase 2b Randomized Clinical Trial. Crit Care Med. 2021 Apr 1;49(4):e369-e380. doi: 10.1097/CCM.0000000000004848.
- Derived from this study: PubMed 33372745Faustino EVS, Shabanova V, Raffini LJ, Kandil SB, Li S, Pinto MG, Cholette JM, Hanson SJ, Nellis ME, Silva CT, Chima R, Sharathkumar A, Thomas KA, McPartland T, Tala JA, Spinella PC; CRETE Trial Investigators and the Pediatric Critical Care Blood Research Network (BloodNet) of the Pediatric Acute Lung Injury and Sepsis Investigators Network (PALISI). Efficacy of Early Prophylaxis Against Catheter-Associated Thrombosis in Critically Ill Children: A Bayesian Phase 2b Randomized Clinical Trial. Crit Care Med. 2021 Mar 1;49(3):e235-e246. doi: 10.1097/CCM.0000000000004784.
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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.
E. Vincent S Faustino, MD, MHS principal investigator
Associate Professor of Pediatrics, Yale School of Medicine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enoxaparin in people with Deep Venous Thrombosis, run by Yale University at 6 sites in United States.
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 16 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: stopped early, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Central Venous Catheter (CVC)- Associated Deep Vein Thrombosis (DVT) (time frame: Up to removal of CVC, an average of 6 days). 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?
On the ClinicalTrials.gov record for NCT03003390, which also lists 2 linked publications.
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 13 Jul 2020.