Venous Thromboembolism (VTE)Phase 3NCT06628778
Collaborative Risk-stratified Investigation in Thrombosis-prone Inpatients With Critical Illness: Anticoagulation With LMWH in Teens for ThromboProphylaxis (CRITICAL-Teens-TP).
A Phase 3 study testing Enoxaparin in people with Venous Thromboembolism (VTE), run by Johns Hopkins All Children's Hospital at 1 site in United States.
Trial summary
Critically ill adolescents are at greatest risk for developing hospital-acquired venous thromboembolism. To date, no phase 3 randomized controlled trials have been conducted for pharmacological thromboprophylaxis as primary venous thromboembolism prevention in children. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Venous Thromboembolism (VTE)
- 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
- 802 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2027to 15 Apr 2035
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Admission Age between 12- 18 years of age
- Within 24 hours of pediatric intensive care unit (PICU) admission for enrollment
- Presence of a Central Venous Catheter
- Presumed or confirmed infection or systemic inflammatory condition
Who cannot join
- Active treatment for VTE or known VTE present prior to or on pediatric intensive care unit (PICU) admission
- Current receipt of an antithrombotic agent excluding unfractionated heparin for vascular catheter patency
- Active ISTH-defined clinically relevant bleeding
- Surgery in the last 7-days
- Major trauma within the last 7-days
- Admission for management of congenital heart disease including perioperative management of critical congenital heart disease
Show all 14Show fewer
- Presence of coagulopathy including:
- International normalized ratio (INR) 2.0 activated partial thromboplastin time (aPTT) 50 seconds Platelet count 50 x103/mL
- Creatinine clearance 30 ml/min/1.73 m2
- Known hypersensitivity to heparin or pork products
- Laboratory confirmed heparin induced thrombocytopenia
- Current pregnancy or lactation,
- Presence of an epidural catheter
- Prior enrollment in the CRITICAL-Teens-TP Trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Johns Hopkins All Children"s Hospital
St. Petersburg, Florida, 33704
Anthony A Sochet, 727-767-2912, Sochet@jhmi.edu
Anthony A Sochet, MD, MSc
About this study
Official title: Collaborative Risk-stratified Investigation in Thrombosis-prone Inpatients With Critical Illness: Anticoagulation With LMWH in Teens for ThromboProphylaxis (CRITICAL-Teens-TP)
Critically ill adolescents are at greatest risk for developing hospital-acquired venous thromboembolism. To date, no phase 3 randomized controlled trials have been conducted for pharmacological thromboprophylaxis as primary venous thromboembolism prevention in children. The investigators will perform a United States definitive multicenter phase 3 randomized controlled trial of the low molecular weight heparin enoxaparin as primary venous thromboembolism prophylaxis among critically ill adolescents who are classified a priori as high risk based upon the investigators validated risk prediction models.
Read the detailed description
This trial will establish definitive evidence on the comparative efficacy and safety of pharmacological thromboprophylaxis with the low molecular weight heparin (LMWH) enoxaparin versus no pharmacological thromboprophylaxis for the primary prevention of venous thromboembolism (VTE), including deep vein thrombosis and/or pulmonary embolism) among critically ill adolescents who meet a priori criteria for high risk of hospital-acquired (HA-) VTE. In the past two decades, the diagnosis of pediatric hospital-acquired VTE (HA-VTE) in the U.S. has increased 130-200-fold. The investigators have shown that critically-ill adolescents are one the highest risk subpopulations for HA-VTE, with average occurrence rates of 13.2% (range: 6.3-19.8%), and have derived and prospectively validated risk models for HA-VTE in this population. Despite a simultaneously increased risk of bleeding in critically ill adolescents, particularly after surgery or major trauma, an investigator-initiated multicenter phase 2 trial recently led by the investigators group during the COVID-19 pandemic demonstrated the safety of LMWH for primary HA-VTE prevention. To date, risk-stratified phase 3 Randomized Controlled Trials (RCTs) of LMWH thromboprophylaxis as primary HA-VTE prevention in children have not been performed. The investigators will perform a U.S.-based definitive multicenter phase 3 RCT of the LMWH enoxaparin versus no pharmacological thromboprophylaxis for VTE prevention among critically ill adolescents at highest a priori risk for HA-VTE applying evidence from the investigators published risk prediction models.
- Conditions
- Venous Thromboembolism (VTE)
- Being tested
- Enoxaparin
- Keywords
- pediatric, adolescent, critical illness, thromboprophylaxis
- Medical subject headings
- Venous Thromboembolism, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
Enoxaparin thromboprophylaxis administered subcutaneously twice daily (every 12 hours) from enrollment through pediatric intensive care unit discharge
| Study group | Role | What they receive |
|---|---|---|
| EnoxaparinThromboprophylaxis | Experimental | This arm will receive the study intervention, enoxaparin thromboprophylaxis during pediatric intensive care unit hospitalization Receives: Drug: Enoxaparin |
| No Pharmacological Thromboprophylaxis | No intervention | This arm will receive no pharmacological thromboprophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk (i.e., cumulative incidence) of Symptomatic venous thromboembolism
International Society on Thrombosis and Haemostasis (ISTH) defined symptomatic venous thromboembolism
Measured: From randomization through discharge from the pediatric intensive care unit, approximately 1-2 weeks
Risk (i.e., cumulative incidence) of Clinically relevant bleeding
International Society on Thrombosis and Haemostasis (ISTH) defined clinically relevant bleeding (Major bleeding + Clinically relevant Non-major bleeding)
Measured: From randomization through discharge from the pediatric intensive care unit, approximately 1-2 weeks
Secondary outcomes (4)
Net Clinical Benefit - Modelled Attributable Risk Difference in HA-VTE (Efficacy) by Attributable Risk Difference in clinically relevant bleeding (Safety)
Net clinical benefit is a bivariate endpoint analysis (i.e., trade-off of venous thromboembolism and bleeding risks as described below). One-year risks and corresponding 95% confidence intervals (CI) of hospital-acquired venous thromboembolism and clinically relevant bleeding for each study arm will be calculated from weighted Kaplan-Meier curves. A bivariate decision curve will be specified using the 12-month absolute risk difference for venous thromboembolism and bleeding outcomes. Bivariate outcomes for enoxaparin and no pharmacological thromboprophylaxis will be compared under a hypothesis of superiority using the superiority boundary of a bivariate endpoint analysis, with inference based on the 95% confidence rectangle (i.e., the rectangle defined by the 95% CI for hospital-acquired venous thromboembolism absolute risk difference and the 95% CI for bleeding absolute risk difference). Superiority will be decided if the 95% confidence rectangle rules out the superiority curve.
Measured: From randomization through discharge from the pediatric intensive care unit, approximately 1-2 weeks
Risk (i.e. cumulative incidence) of symptomatic venous thromboembolism
International Society on Thrombosis and Haemostasis-defined symptomatic venous thromboembolism
Measured: From randomization through 30-days post discharge from the pediatric intensive care unit
Risk (i.e. cumulative incidence) of clinically relevant bleeding
International Society on Thrombosis and Haemostasis-defined clinically relevant bleeding (Major Bleeding + Clinically Relevant Non-Major Bleeding)
Measured: From randomization through 30-days post discharge from the pediatric intensive care unit
Serious adverse events
As federally defined.
Measured: From randomization through 30-days post discharge from the pediatric intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start15 Apr 2027 (estimated)
- Primary completion15 Apr 2034 (estimated)
- Study completion15 Apr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous Thromboembolism (VTE)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PROBE study design, Randomized allocation 2:1 (Intervention:Standard of care) of enoxaparin thromboprophylaxis versus standard-of-care (i.e., no pharmacological thromboprophylaxis). Analytic study populations will be modified intent-to-treat, per-protocol, and safety populations
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 802 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Anthony Sochet, MD, MSc, Principal investigator, Johns Hopkins All Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628778
- Sponsor's protocol ID
- IRB00507234-CRITICAL-Teens-TP
- Status last verified
- May 2026
- First submitted
- 30 Sep 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Sochet AA, Amankwah EK, Andalib V, Jaffray J, Male C, Faustino EV, Goldenberg NA; Pedi-ATLAS Group and the Antithrombotic Trials Working Party of the Pediatric Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Enhanced trial efficiency of the novel "contemporaneous control recapture" parallel-cohort RCT design: Methods and application in the CRITICAL-Kids-TP trial. Contemp Clin Trials. 2026 Jan;160:108142. doi: 10.1016/j.cct.2025.108142. Epub 2025 Nov 10.
PubMed 41223938
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Risk-stratified Investigation in Thrombosis-prone Inpatients With Critical Illness: Anticoagulation With LMWH in Teens for ThromboProphylaxis (CRITICAL-Teens-TP)
- ClinicalTrials.gov ID
- NCT06628778
- Acronym / sponsor ID
- IRB00507234-CRITICAL-Teens-TP
- Conditions
- Venous Thromboembolism (VTE)
- Keywords
- pediatric, adolescent, critical illness, thromboprophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 802 participants (estimated)
- Lead sponsor
- Johns Hopkins All Children's HospitalUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- 15 Apr 2027 (estimated)
- Primary completion
- 15 Apr 2034 (estimated)
- Study completion
- 15 Apr 2035 (estimated)
- First posted
- 8 Oct 2024 (actual)
- 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.
Critically ill adolescents are at greatest risk for developing hospital-acquired venous thromboembolism. To date, no phase 3 randomized controlled trials have been conducted for pharmacological thromboprophylaxis as primary venous thromboembolism prevention in children. The investigators will perform a United States definitive multicenter phase 3 randomized controlled trial of the low molecular weight heparin enoxaparin as primary venous thromboembolism prophylaxis among critically ill adolescents who are classified a priori as high risk based upon the investigators validated risk prediction models.
Detailed description
This trial will establish definitive evidence on the comparative efficacy and safety of pharmacological thromboprophylaxis with the low molecular weight heparin (LMWH) enoxaparin versus no pharmacological thromboprophylaxis for the primary prevention of venous thromboembolism (VTE), including deep vein thrombosis and/or pulmonary embolism) among critically ill adolescents who meet a priori criteria for high risk of hospital-acquired (HA-) VTE. In the past two decades, the diagnosis of pediatric hospital-acquired VTE (HA-VTE) in the U.S. has increased 130-200-fold. The investigators have shown that critically-ill adolescents are one the highest risk subpopulations for HA-VTE, with average occurrence rates of 13.2% (range: 6.3-19.8%), and have derived and prospectively validated risk models for HA-VTE in this population. Despite a simultaneously increased risk of bleeding in critically ill adolescents, particularly after surgery or major trauma, an investigator-initiated multicenter phase 2 trial recently led by the investigators group during the COVID-19 pandemic demonstrated the safety of LMWH for primary HA-VTE prevention. To date, risk-stratified phase 3 Randomized Controlled Trials (RCTs) of LMWH thromboprophylaxis as primary HA-VTE prevention in children have not been performed. The investigators will perform a U.S.-based definitive multicenter phase 3 RCT of the LMWH enoxaparin versus no pharmacological thromboprophylaxis for VTE prevention among critically ill adolescents at highest a priori risk for HA-VTE applying evidence from the investigators published risk prediction models.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- PROBE study design, Randomized allocation 2:1 (Intervention:Standard of care) of enoxaparin thromboprophylaxis versus standard-of-care (i.e., no pharmacological thromboprophylaxis). Analytic study populations will be modified intent-to-treat, per-protocol, and safety populations
| Arm | Type | Receives |
|---|---|---|
| EnoxaparinThromboprophylaxis | Experimental | Drug: EnoxaparinThis arm will receive the study intervention, enoxaparin thromboprophylaxis during pediatric intensive care unit hospitalization |
| No Pharmacological Thromboprophylaxis | No intervention | –This arm will receive no pharmacological thromboprophylaxis |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Admission Age between 12- 18 years of age
- Within 24 hours of pediatric intensive care unit (PICU) admission for enrollment
- Presence of a Central Venous Catheter
- Presumed or confirmed infection or systemic inflammatory condition
Key exclusion criteria (14 listed)
- Active treatment for VTE or known VTE present prior to or on pediatric intensive care unit (PICU) admission
- Current receipt of an antithrombotic agent excluding unfractionated heparin for vascular catheter patency
- Active ISTH-defined clinically relevant bleeding
- Surgery in the last 7-days
- Major trauma within the last 7-days
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 |
|---|---|---|
| EnoxaparinEnoxaparin thromboprophylaxis administered subcutaneously twice daily (every 12 hours) from enrollment through pediatric intensive care unit discharge | Drug | EnoxaparinThromboprophylaxis |
Primary outcome
Risk (i.e., cumulative incidence) of Symptomatic venous thromboembolism
Time frame: From randomization through discharge from the pediatric intensive care unit, approximately 1-2 weeks
International Society on Thrombosis and Haemostasis (ISTH) defined symptomatic venous thromboembolism
Risk (i.e., cumulative incidence) of Clinically relevant bleeding
Time frame: From randomization through discharge from the pediatric intensive care unit, approximately 1-2 weeks
International Society on Thrombosis and Haemostasis (ISTH) defined clinically relevant bleeding (Major bleeding + Clinically relevant Non-major bleeding)
4 secondary outcomes
Net Clinical Benefit - Modelled Attributable Risk Difference in HA-VTE (Efficacy) by Attributable Risk Difference in clinically relevant bleeding (Safety)
Time frame: From randomization through discharge from the pediatric intensive care unit, approximately 1-2 weeks
Risk (i.e. cumulative incidence) of symptomatic venous thromboembolism
Time frame: From randomization through 30-days post discharge from the pediatric intensive care unit
Risk (i.e. cumulative incidence) of clinically relevant bleeding
Time frame: From randomization through 30-days post discharge from the pediatric intensive care unit
Serious adverse events
Time frame: From randomization through 30-days post discharge from the pediatric intensive care unit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Derived from this study: PubMed 41223938Sochet AA, Amankwah EK, Andalib V, Jaffray J, Male C, Faustino EV, Goldenberg NA; Pedi-ATLAS Group and the Antithrombotic Trials Working Party of the Pediatric Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Enhanced trial efficiency of the novel "contemporaneous control recapture" parallel-cohort RCT design: Methods and application in the CRITICAL-Kids-TP trial. Contemp Clin Trials. 2026 Jan;160:108142. doi: 10.1016/j.cct.2025.108142. Epub 2025 Nov 10.
- Individual participant dataSharing planned: Yes
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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.
Anthony Sochet, MD, MSc principal investigator
Johns Hopkins All Children's Hospital
1 site in 1 country: 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 (VTE), run by Johns Hopkins All Children's Hospital at 1 site 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 14 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: opening soon, as of the sponsor's last update on 26 May 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony A Sochet, MD, MSc (727-767-2912, sochet@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk (i.e., cumulative incidence) of Symptomatic venous thromboembolism (time frame: From randomization through discharge from the pediatric intensive care unit, approximately 1-2 weeks). 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 NCT06628778, which also lists 1 linked publication.
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 26 May 2026.