Subcutaneous Heparin for Respiratory Insufficiency

Overseen By Tammy Fisher

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Baylor Research Institute

Must not be taking: Heparin

Disqualifiers: Other trial, HIT, PFO, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new method of administering heparin, a blood thinner, works safely and effectively for individuals with serious breathing problems who require VV-ECMO, a machine that aids breathing. It compares subcutaneous heparin anticoagulation (injecting heparin just under the skin) with the usual intravenous method. Suitable candidates for this trial include those with severe breathing difficulties needing VV-ECMO support. However, individuals with a history of adverse reactions to heparin or certain medical conditions, such as recent major surgery, should not participate. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how it can benefit more patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the safety track record for subcutaneous heparin anticoagulation?

Studies have shown that subcutaneous heparin, a blood-thinning medication, is generally safe but carries some risks. In one study, about 1.9% of people using heparin experienced significant bleeding. Serious blood clots that were fatal occurred in 0.7% of patients, and bleeding was fatal in 0.2% of cases. Although these events are rare, they are important to consider.

Another study found that a full dose of heparin led to bleeding in 1.7% of patients. Common side effects include bleeding and, less often, a decrease in platelets, known as heparin-induced thrombocytopenia (HIT).

Overall, while some risks exist, subcutaneous heparin is generally well-tolerated. The treatment is already approved for other conditions, indicating it has been studied and found safe for use in humans. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatment for respiratory insufficiency, which often involves systemic intravenous anticoagulation, subcutaneous heparin is administered directly under the skin. This delivery method is less invasive and easier to manage, potentially improving patient comfort and compliance. Researchers are excited because subcutaneous heparin could offer a safer and equally effective alternative, minimizing the risk of bleeding complications associated with intravenous administration.

What evidence suggests that subcutaneous heparin anticoagulation might be an effective treatment for respiratory failure?

Research has shown that subcutaneous heparin, a blood thinner injected under the skin, may reduce death rates in patients with severe breathing problems like ARDS (Acute Respiratory Distress Syndrome). In this trial, participants will receive either subcutaneous heparin anticoagulation or systemic intravenous anticoagulation as part of the study arms. Some studies found that heparin improved health outcomes in patients hospitalized with COVID-19. However, higher doses of heparin can increase the risk of serious bleeding. Heparin's ability to prevent blood clots and improve blood flow makes it a promising option for treating breathing issues. Overall, heparin has been effective in similar conditions, suggesting it could help with respiratory failure. ^{6 7 8 9 10}

Who Is on the Research Team?

Gary Schwartz, MD

Principal Investigator

BSWH

Are You a Good Fit for This Trial?

This trial is for patients with respiratory failure who need VV-ECMO support and can consent to participate. It's not for those in another study, allergic to heparin, with a history of HIT or PFO, recent surgery, intracranial bleed, or needing anticoagulation for reasons other than ECMO.

Inclusion Criteria

Respiratory failure requiring VV-ECMO support

Subject or appointed health care proxy/LAR is able to understand and sign the informed consent form

Exclusion Criteria

Subject currently enrolled in another interventional research trial

History of hypersensitivity/adverse reaction to heparin

Proven Heparin induced thrombocytopenia (HIT)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either subcutaneous heparin or standard intravenous heparin anticoagulation during veno-venous ECMO for respiratory failure

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of bleeding and thrombotic complications

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Subcutaneous Heparin Anticoagulation

Trial Overview The study compares subcutaneous heparin (given under the skin) against standard IV heparin (through the vein) in patients using VV-ECMO due to breathing failure. The goal is to see which method is safer and more effective.

How Is the Trial Designed?

Group I: subcutaneous heparin anticoagulation Experimental Treatment 1 Intervention

Experimental arm

Group II: systemic intravenous anticoagulation Active Control 1 Intervention

SOC arm

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10895755/

Exploring the therapeutic role of early heparin ... This research highlights that early prophylactic administration of heparin may substantially lower mortality in ARDS patients.

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2785004

Efficacy and Safety of Therapeutic-Dose Heparin vs ... The incidence of major bleeding was 1.6% with standard-dose vs 4.7% with therapeutic-dose heparins (RR, 2.88; 95% CI, 0.59-14.02; P = .17). The ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2105911

Therapeutic Anticoagulation with Heparin in Noncritically Ill ... We hypothesized that therapeutic-dose anticoagulation may improve outcomes in noncritically ill patients who are hospitalized with Covid-19.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12210374/

Is an extended dose of subcutaneous nadroparin ... UFH anticoagulation may provide better flow optimization in the oxygenator, but the risk of life-threatening bleeding may increase.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2475037922014947

Randomized trials of therapeutic heparin for COVID‐19 Randomized controlled trials (RCTs) suggest that therapeutic heparin anticoagulation is beneficial in patients hospitalized for COVID‐19 with moderate illness.

6. nature.com nature.com/articles/s41598-025-01527-9

Safety comparisons among different subcutaneous ... For clinical outcomes, fondaparinux had the highest hospitalization rate (51.88%), compared to 44.58% for enoxaparin and 40.42% for dalteparin.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK525957/

Low-Molecular-Weight Heparin (LMWH) - StatPearls - NCBI As an anticoagulant, the main risk of LMWH is bleeding. Less common adverse effects include heparin-induced thrombocytopenia, osteoporosis, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9362611/

Efficacy and safety of heparin full-dose anticoagulation in ... Clinical relevant bleeding events occurred in 1.7% (26/1524) among patients treated with heparin full anticoagulation dose compared to 1.1% (15/ ...

9. ahajournals.org ahajournals.org/doi/10.1161/01.cir.103.24.2994

Guide to Anticoagulant Therapy: Heparin | Circulation The rate of major bleeding was 1.9%, fatal recurrent venous thromboembolism occurred in 0.7%, and bleeding was fatal in 0.2% of heparin-treated patients. The ...

10. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/1904827

Clinical and Safety Outcomes Associated With Treatment of ... Untreated acute pulmonary embolism is associated with a mortality rate of up to 25%. Anticoagulant therapy is effective at treating acute venous ...