The purpose of this study is to evaluate the safety, dose-requirements, and exploratory efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection (i.e., COVID-19).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
40
Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 m/gkg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL)
Children's of Alabama
Birmingham, Alabama, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Safety of In-hospital Thromboprophylaxis as Assessed by Number of Participants With ISTH-defined Clinically-relevant Bleeding Events During Hospitalization
The safety of in-hospital thromboprophylaxis with twice-daily low-dose enoxaparin thromboprophylaxis will be measured by cumulative incidence (number of participants) of ISTH-defined clinically-relevant bleeding events during hospitalization. Clinically relevant bleeding episodes may include any of the following: 1. fatal bleeding; 2. clinically overt bleeding associated with a decline in hemoglobin of ≥2g/dL in a 24h period; 3. retroperitoneal, pulmonary, or central nervous system bleeding; 4. bleeding requiring surgical intervention in an operating suite; 5. bleeding for which a blood product is administered (blood product administration not directly attributable to the patient's underlying condition); 6. bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating suite.
Time frame: Day 30
Median Twice-daily Enoxaparin Dose Required to Achieve 4-hour Post-dose Anti-factor Xa Between 0.20-0.49 U/mL
The median twice-daily enoxaparin dose, as measured in mg/kg, required to achieve a 4-hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL in children hospitalized with COVID-19, and to compare dose-requirements by age group (\<12 and those \>12 years of age).
Time frame: 4 hours post initial dose
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Hemostasis and Thrombosis Center UC Davis
Sacramento, California, United States
Rady Children's Hospital
San Diego, California, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Children's Hospital of Atlanta
Atlanta, Georgia, United States
Lurie Children's Hospital
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Children's Hospital New Orleans
New Orleans, Louisiana, United States
Johns Hopkins Hospital and Children's Center
Baltimore, Maryland, United States
...and 6 more locations