Dalteparin for Blood Clots (CRITICALKidsTP Trial)

Palo Alto (17 mi)

Overseen byAnthony Sochet, MD

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Johns Hopkins All Children's Hospital

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?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 dalteparin 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.

Eligibility Criteria

This trial is for critically ill adolescents at high risk of developing blood clots while in the hospital. Participants must be identified as high-risk using specific prediction models but details on exact inclusion and exclusion criteria are not provided.

Inclusion Criteria

I am between 12 and 18 years old.

I have an infection or inflammation.

Exclusion Criteria

I am currently taking blood thinners, but not unfractionated heparin for a catheter.

I have not had surgery in the past week.

I am being admitted for treatment related to my congenital heart disease.

I am receiving treatment for a blood clot or had one before or upon entering the PICU.

Treatment Details

The study tests if dalteparin, a low molecular weight heparin, can prevent blood clots in hospitalized teens who are critically ill. It's a phase 3 trial where patients are randomly chosen to receive either dalteparin or a control treatment.

2Treatment groups

Experimental Treatment

Active Control

Group I: Dalteparin ThromboprophylaxisExperimental Treatment1 Intervention

This arm will receive the study intervention, dalteparin thromboprophylaxis during pediatric intensive care unit hospitalization

Group II: Standard-of-Care ArmActive Control1 Intervention

This arm will receive standard of care (i.e., no pharmacological thromboprophylaxis)

Dalteparin is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Fragmin for:

Prevention of deep vein thrombosis
Treatment of deep vein thrombosis
Prevention of pulmonary embolism
Treatment of unstable angina and non-Q-wave myocardial infarction

🇺🇸 Approved in United States as Fragmin for:

Prevention of deep vein thrombosis
Treatment of acute deep vein thrombosis
Extended treatment of deep vein thrombosis
Prevention of ischemic complications in unstable angina and non-Q-wave myocardial infarction

🇨🇦 Approved in Canada as Fragmin for: