NCT03003390 (CRETE) is a Phase 2 clinical trial of Enoxaparin in Deep Venous Thrombosis, sponsored by Yale University.

Who is sponsoring NCT03003390?

NCT03003390 is sponsored by Yale University.

What drugs are being tested in NCT03003390?

Interventions in NCT03003390: Enoxaparin.

What condition does NCT03003390 study?

NCT03003390 studies Deep Venous Thrombosis.

Is NCT03003390 still recruiting?

NCT03003390 is currently terminated. Last updated 13 July 2020.

Are results published for NCT03003390?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-07-13 · How we verify

NCT03003390: CRETE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Catheter-Related Early Thromboprophylaxis With Enoxaparin (CRETE) Trial

Terminated Phase 2 Results posted Last updated 13 July 2020

What this trial tests

Phase 2 trial testing Enoxaparin in Deep Venous Thrombosis in 51 participants. Terminated before completion.

Timeline

5 April 2017

Primary endpoint
16 August 2019

16 August 2019

Quick facts

Lead sponsor	Yale University
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	51
Start date	5 April 2017
Primary completion	16 August 2019
Estimated completion	16 August 2019
Sites	6 locations across United States

Drugs / interventions tested

Enoxaparin — full drug profile →

Conditions studied

Deep Venous Thrombosis — all drugs for Deep Venous Thrombosis →

Sponsor

Yale University

Who can join

Under 17, any sex, with Deep Venous Thrombosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Central Venous Catheter (CVC)- Associated Deep Vein Thrombosis (DVT) Primary · 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

Group	Value	95% CI
Prophylaxis With Enoxaparin	7
Control Arm	13

Endogenous Thrombin Potential Primary · 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.

Day of CVC Insertion

Group	Value	95% CI
Prophylaxis With Enoxaparin	919.7	418.71 – 1150.77
Control Arm	1035.6	800.22 – 1455.05

Day After CVC Insertion

Group	Value	95% CI
Prophylaxis With Enoxaparin	851.19	627.31 – 995.98
Control Arm	896.58	433.9 – 1331.03

Day 4 After CVC Insertion

Group	Value	95% CI
Prophylaxis With Enoxaparin	826.97	0 – 1131.7
Control Arm	969.89	605.35 – 1302.95

Number With Other Thromboembolic Events Secondary · Up to removal of CVC, an average of 6 days

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

Group	Value	95% CI
Prophylaxis With Enoxaparin	1
Control Arm	1

Length of Stay in the Pediatric Intensive Care Unit in Days Secondary · Up to day of discharge from the pediatric intensive care unit, an average of 10 days

Duration of stay in the pediatric intensive care unit from the day of enrollment

Group	Value	95% CI
Prophylaxis With Enoxaparin	12	6 – 22
Control Arm	8	4 – 16

Length of Stay in the Hospital Secondary · Up to day of discharge from the hospital, an average of 18 days

Duration of stay in the hospital from the day of enrollment

Group	Value	95% CI
Prophylaxis With Enoxaparin	16	6 – 35
Control Arm	16	7 – 23

Number With Clinically Relevant Bleeding Secondary · Up to 30 hours after the last enoxaparin dose

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

Group	Value	95% CI
Prophylaxis With Enoxaparin	1
Control Arm	0

Number With Laboratory Confirmed Heparin-induced Thrombocytopenia Secondary · Up to removal of CVC, an average of 6 days

Heparin-induced thrombocytopenia that is diagnosed with a positive serotonin release assay

Group	Value	95% CI
Prophylaxis With Enoxaparin	0
Control Arm	0

Number of Mortality Secondary · Up to day of discharge from the hospital, average of 18 days

In-hospital mortality during the subject's admission

Group	Value	95% CI
Prophylaxis With Enoxaparin	5
Control Arm	2

Number of Enrolled Eligible Children Secondary · Up to 24 hours after insertion of CVC

Number of eligible children enrolled in the study.

Group	Value	95% CI
Eligible Children	51

Time to 1st Dose of Enoxaparin Secondary · Up to 48 hours after insertion of CVC

Time to first dose of enoxaparin

Group	Value	95% CI
Prophylaxis With Enoxaparin	21.1	14.7 – 23.5

Time to Target Anti-Xa Activity Secondary · Up to removal of CVC, an average of 6 days

Time from insertion of the CVC to time that anti-Xa activity was within 0.2-0.5 IU/mL.

Group	Value	95% CI
Prophylaxis With Enoxaparin	70.4	47.4 – 92.2

Number of Missed Doses of Enoxaparin Secondary · Up to removal of CVC, an average of 6 days

Number of doses of enoxaparin that were not administered. This outcome measure was only applicable to the enoxaparin arm.

Group	Value	95% CI
Prophylaxis With Enoxaparin	8

Adverse events — posted to ClinicalTrials.gov

Time frame: From hospital admission to day of discharge for death, up to 60 days.. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Prophylaxis With Enoxaparin

Serious: 2/27 (7%)

Deaths: 5/27

Control Arm

Serious: 0/24 (0%)

Deaths: 2/24

Serious adverse events (2 terms)

Reaction	System	Prophylaxis With Enoxaparin	Control Arm
acute kidney injury	Renal and urinary disorders	—	—
Cardiac arrest	Cardiac disorders	—	—

Other adverse events (19 terms — click to expand)

Reaction	System	Prophylaxis With Enoxaparin	Control Arm
Anemia	Blood and lymphatic system disorders	—	—
Acidosis	Metabolism and nutrition disorders	—	—
Hypoalbuminemia	Metabolism and nutrition disorders	—	—
Tracheitis	Infections and infestations	—	—
Aspiration	Respiratory, thoracic and mediastinal disorders	—	—
Edema trunk	General disorders	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—
General disorders and administration site conditions - Other, specify	General disorders	—	—
Hematuria	Renal and urinary disorders	—	—
Hypernatremia	Metabolism and nutrition disorders	—	—
Hypocalcemia	Metabolism and nutrition disorders	—	—
Hypoglycemia	Metabolism and nutrition disorders	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—
Hypophosphatemia	Metabolism and nutrition disorders	—	—
Hypotension	Vascular disorders	—	—
Oral hemorrhage	Gastrointestinal disorders	—	—
Platelet count decreased	Investigations	—	—
Seizure	Nervous system disorders	—	—
Thromboembolic event	Vascular disorders	—	—

Most-reported serious reactions: acute kidney injury, Cardiac arrest.

Data from ClinicalTrials.gov NCT03003390 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy of Early Prophylaxis Against Catheter-Associated Thrombosis in Critically Ill Children: A Bayesian Phase 2b Randomized Clinical Trial.
Faustino EVS, Shabanova V, Raffini LJ, Kandil SB, et al · · 2021 · cited 37× · PMID 33372745 · DOI 10.1097/ccm.0000000000004784
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.
Faustino EVS, Raffini LJ, Hanson SJ, Cholette JM, et al · · 2021 · cited 18× · PMID 33566465 · DOI 10.1097/ccm.0000000000004848
Low molecular weight heparin for prevention of central venous catheter-related thrombosis in children.
Pelland-Marcotte MC, Amiri N, Avila ML, Brandão LR. · · 2020 · cited 6× · PMID 32557627 · DOI 10.1002/14651858.cd005982.pub3
COVID-19 pandemic and enrollment of critically Ill children in randomized clinical trials.
Kandil SB, Panisello-Manterola D, Chegondi M, Allen C, et al · · 2025 · PMID 41378199 · DOI 10.3389/fped.2025.1704390

Verify or expand the search:

Other trials of Enoxaparin

Trials testing the same drug.

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NCT06689241 — Rivaroxaban Versus Enoxaparin for Prophylaxis of Venous Thromboembolism in Bariatric Surgery · NA · recruiting

Other recruiting trials for Deep Venous Thrombosis

Currently open trials in the same condition.

NCT07399977 — Using a Blood Test and Software Tool to Guide Treatment for Venous Thromboembolism · NA · recruiting
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NCT06913595 — Low Molecular Weight Heparin vs Direct Oral Anticoagulant After Bariatric Surgery · Phase 1 · active not recruiting
NCT05701917 — DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis · NA · recruiting
NCT04924322 — Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies · Phase 2, PHASE3 · recruiting

Other Yale University trials

Trials by the same sponsor.

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NCT07398404 — A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Pa · Phase 1, PHASE2 · not yet recruiting
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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03003390 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yale University
Last refreshed: 13 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03003390.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing