Dalteparin for Blood Clots

(CRITICALKidsTP Trial)

Overseen By Anthony A Sochet, MD, MSc

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Johns Hopkins All Children's Hospital

Must not be taking: Antithrombotics

Disqualifiers: VTE, Bleeding, Surgery, Trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

802 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently receiving an antithrombotic agent, except for unfractionated heparin for catheter patency.

What data supports the effectiveness of the drug Dalteparin for treating blood clots?

Dalteparin, a low molecular weight heparin, has been shown to be effective in preventing and treating blood clots, such as deep vein thrombosis (DVT), with studies indicating it is as effective as traditional heparin and can be used safely in outpatient settings. It has also been found effective in combination with aspirin for managing unstable coronary artery disease and in preventing clotting during dialysis. ^{1 2 3 4 5}

Is Dalteparin (Fragmin) safe for humans?

Dalteparin (Fragmin) has been studied in various clinical trials and is generally considered safe for humans. It has been used for preventing and treating blood clots, with studies showing no severe adverse reactions or drug-related deaths. However, like any medication, it may have side effects, and its safety can depend on individual health conditions. ^{1 2 6 7 8}

How is the drug Dalteparin different from other treatments for blood clots?

Dalteparin is a low molecular weight heparin (LMWH) that offers improved bioavailability and a longer duration of action compared to standard heparin, allowing for once-daily subcutaneous injections. This makes it more convenient for patients, especially for outpatient treatment, and it has been shown to be as effective and safe as traditional heparin in treating deep vein thrombosis (DVT). ^{1 2 5 6 9}

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.

Research Team

Anthony Sochet, MD

Principal Investigator

Johns Hopkins All Children's Hospital

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

Presence of a Central Venous Catheter

Within 24 hours of pediatric intensive care unit (PICU) admission for enrollment

Anticipated PICU Length of Stay /= 4 days

Exclusion Criteria

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

Prior enrollment in the CRITICAL-Kids-TP Trial

Presence of an epidural catheter

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dalteparin thromboprophylaxis or standard of care during pediatric intensive care unit hospitalization

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of venous thromboembolism and bleeding risks

30 days post discharge

Treatment Details

Interventions

• Dalteparin

Trial Overview 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.

Participant Groups

Group I: Dalteparin Thromboprophylaxis Experimental Treatment 1 Intervention

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

Group II: Standard-of-Care Arm Active Control 1 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:

• Prevention of deep vein thrombosis
• Treatment of deep vein thrombosis
• Prevention of pulmonary embolism

Who Is Running the Clinical Trial?

Johns Hopkins All Children's Hospital

Lead Sponsor

Trials

47

Recruited

5,009,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Findings from Research

Dalteparin sodium is a low molecular weight heparin that offers improved bioavailability and prolonged antithrombotic activity compared to unfractionated heparin, allowing for once-daily administration.

It has been extensively studied in randomized clinical trials for various thrombotic disorders and is approved for multiple clinical uses, including the prevention of thromboembolic events after surgery and the long-term treatment of deep vein thrombosis, although further research is needed for some applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dalteparin sodium. Pineo, GF., Hull, RD.[2019]

Dalteparin, a low molecular weight heparin, is as effective as unfractionated heparin for preventing blood clots, with a simpler once-daily subcutaneous administration that enhances patient compliance and reduces hospital costs.

It has been shown to have a lower risk of bleeding complications compared to unfractionated heparin, making it a safer option for both surgical thromboprophylaxis and the treatment of conditions like deep vein thrombosis and unstable coronary artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dalteparin: an update of its pharmacological properties and clinical efficacy in the prophylaxis and treatment of thromboembolic disease. Dunn, CJ., Jarvis, B.[2018]

In a study of 119 patients with deep venous thrombosis (DVT), treatment with low molecular weight heparin (Fragmin) was found to be as effective as standard heparin (SH) in improving venous conditions, with 76% of Fragmin patients showing improvement compared to 61% in the SH group after 5-7 days.

Fragmin demonstrated a better safety profile, with no major bleeding incidents reported, while the SH group had two cases of major bleeding, suggesting that Fragmin may be a safer option for DVT treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two daily subcutaneous injections of fragmin as compared with intravenous standard heparin in the treatment of deep venous thrombosis (DVT). Bratt, G., Aberg, W., Johansson, M., et al.[2006]

References

1. England pubmed.ncbi.nlm.nih.gov

Dalteparin sodium. [2019]

2. Sweden pubmed.ncbi.nlm.nih.gov

[Simplified ambulatory treatment of thrombosis. A daily dosage of subcutaneous low-molecular-weight heparin]. [2006]

3. Germany pubmed.ncbi.nlm.nih.gov

A 6-month venographic follow-up in 164 patients with acute deep vein thrombosis. [2013]

4. England pubmed.ncbi.nlm.nih.gov

The assay of overall haemostasis potential used to monitor the low molecular mass (weight) heparin, dalteparin, treatment in pregnant women with previous thromboembolism. [2019]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Dalteparin: an update of its pharmacological properties and clinical efficacy in the prophylaxis and treatment of thromboembolic disease. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Two daily subcutaneous injections of fragmin as compared with intravenous standard heparin in the treatment of deep venous thrombosis (DVT). [2006]

7. Germany pubmed.ncbi.nlm.nih.gov

A double-blind randomized placebo controlled trial of thromboprophylaxis in major elective general surgery using once daily injections of a low molecular weight heparin fragment (Fragmin). [2007]

8. Germany pubmed.ncbi.nlm.nih.gov

Subcutaneous low-molecular-weight heparin fragmin versus intravenous unfractionated heparin in the treatment of acute non massive pulmonary embolism: an open randomized pilot study. [2013]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of low molecular weight heparin (fragmin) on bleeding after cardiac surgery. [2019]