Dalteparin for Blood Clots

(CRITICALKidsTP Trial)

Not yet recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the medication dalteparin can prevent blood clots in critically ill adolescents in intensive care. Blood clots, known as venous thromboembolism, pose a serious risk for these young patients, especially those with central venous catheters and infections. Participants will receive either dalteparin or the usual care without this medication. Adolescents who have been in the ICU for less than 24 hours and are expected to stay for at least four days are suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that dalteparin is likely to be safe for critically ill adolescents?

Research has shown that dalteparin is generally safe for use. Studies have found it effectively lowers the risk of blood clots without significantly increasing the chance of serious bleeding. In one study, participants taking dalteparin experienced nearly half the number of blood clots compared to those not taking it. Another study found no major safety issues, specifically noting that serious bleeding was not more common with dalteparin. The FDA has approved dalteparin for treating blood clots in adults, indicating its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for blood clots?

Unlike the standard of care for blood clots, which often involves no pharmacological intervention in certain cases, dalteparin offers a proactive approach by providing thromboprophylaxis, especially in pediatric intensive care settings. Dalteparin is a low molecular weight heparin, which sets it apart from other anticoagulants due to its predictable absorption and reduced need for frequent monitoring. Researchers are excited about dalteparin because it combines efficacy with a lower risk of bleeding complications, making it a potentially safer option for young patients vulnerable to blood clots.

What evidence suggests that dalteparin might be an effective treatment for blood clots?

Research has shown that dalteparin, which participants in this trial may receive, helps reduce the risk of venous thromboembolism (VTE). One study found that the incidence of VTE dropped from nearly 5% in the group not receiving the drug to about 2.8% in those who did, indicating that dalteparin significantly lowers the chance of developing these clots. Although it did not outperform unfractionated heparin for some very sick patients, dalteparin remains a reliable option for managing VTE. As a type of low molecular weight heparin, dalteparin is commonly used to prevent these dangerous clots. ^{1 2 6 7 8}

Who Is on the Research Team?

Anthony Sochet, MD

Principal Investigator

Johns Hopkins All Children's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15289368/

Randomized, placebo-controlled trial of dalteparin for the ... The incidence of venous thromboembolism was reduced from 4.96% (73 of 1473 patients) in the placebo group to 2.77% (42 of 1518 patients) in the dalteparin group ...

2. ahajournals.org ahajournals.org/doi/10.1161/01.cir.0000138928.83266.24

Randomized, Placebo-Controlled Trial of Dalteparin for the ... The incidence of venous thromboembolism was reduced from 4.96% (73 of 1473 patients) in the placebo group to 2.77% (42 of 1518 patients) in the ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1014475

Dalteparin versus Unfractionated Heparin in Critically Ill ... Among critically ill patients, dalteparin was not superior to unfractionated heparin in decreasing the incidence of proximal deep-vein thrombosis.

4. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/485415

Low-Molecular-Weight Heparin Prophylaxis Using ... The respective overall cumulative frequencies of all deep vein thrombosis were 30 (17.2%) of 174 patients (P<.001), 38 (22.2%) of 171 (P = .003), and 68 (19.7%) ...

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK603711/

Dalteparin - StatPearls - NCBI Bookshelf - NIH Dalteparin sodium is a low molecular weight heparin (LMWH) medication used to manage venous thromboembolism (VTE), deep vein thrombosis (DVT), and ischemic ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1538783622116491

Prolonged prophylaxis with dalteparin to prevent late ... Safety outcomes. Major and minor bleeding events were not increased in the prolonged vs. the short‐term thromboprophylaxis group. Major bleeding occurred in ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/pbc.31215

Retrospective study evaluating safety, clinical effect, and ... There were no documented safety concerns for dalteparin treatment in our study with respect to bleeding events, other thromboembolic events ( ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/020287s080lbl.pdf

highlights of prescribing information - accessdata.fda.gov Patients on preoperative FRAGMIN thromboprophylaxis can be assumed to have altered coagulation. The first postoperative. FRAGMIN thromboprophylaxis dose ...