Catheter-Related Early Thromboprophylaxis With Enoxaparin (CRETE) Trial
Stopped early · Phase 2
Conditions studied: Deep Venous Thrombosis
In brief
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.
Key facts
- Study ID
- NCT03003390
- Run by
- Yale University
- People needed
- 51
- Starts
- 2017-04-05
- Expected to finish
- 2019-08-16
- Last updated by the study team
- 2020-07-13
Who can join
Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- 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
Where it is running
- Yale University Yale New Haven Health — New Haven, Connecticut, United States
- Saint Louis Children's Hospital-Washington University School of Medicine- — St Louis, Missouri, United States
- Weill Cornell Medicine — New York, New York, United States
- University of Rochester Medical Center-Golisano Children's Hospital- — Rochester, New York, United States
- Maria Fareri Children's Hospital — Valhalla, New York, United States
- Children's Hospital of Wisconsin/Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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