Combination Strategies for Catheter Complications

Recruiting in Palo Alto (17 mi)

Overseen by Nishant Sethi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Regional Hospital of Scranton

Must not be taking: Anticoagulants

Disqualifiers: No consent, High heparin dose, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The Safe and Fast Radial Hemostasis using Synergistic Strategies (SAFE \& FAST) trial is an interventional study aimed at reducing the incidence of radial artery occlusion (RAO) rebound bleeding, and the required compression time after transradial approach (TRA) procedures, which have become the default access for coronary procedures globally. The hypothesis is that combining lower-dose heparin and radial hemostasis with simultaneous ipsilateral ulnar artery compression could achieve these improved outcomes.

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

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on long-term anticoagulation therapy (blood thinners) for another reason.

What data supports the effectiveness of the drug Heparin, Heparin sodium, Unfractionated heparin, UFH for catheter complications?

Research shows that heparin can help keep catheters open longer and prevent complications when used in peripheral venous and arterial catheters. ^{1 2 3 4 5}

Is unfractionated heparin (UFH) generally safe for humans?

Unfractionated heparin (UFH) is generally considered safe for use in humans, but it is a high-alert drug with potential side effects like bleeding, heparin-induced thrombocytopenia (a drop in blood platelets), and osteopenia (bone density loss). Careful monitoring and management are essential to minimize these risks. ^{1 2 6 7 8}

How is the drug Heparin different from other treatments for catheter complications?

Heparin is unique because it is used as a catheter lock solution to prevent complications, and it works by preventing blood clots from forming in the catheter. Unlike other treatments, it is a well-established anticoagulant (a substance that prevents blood clotting) and is often compared to alternatives like Acid-citrate-dextrose Formula A for its effectiveness in maintaining catheter function. ^{1 3 4 9 10}

Research Team

Nishant Sethi, MD

Principal Investigator

Regional Hospital of Scranton

Eligibility Criteria

This trial is for individuals who have undergone transradial procedures, such as coronary angiography or interventions. Participants should not currently be experiencing complications like bleeding or artery occlusion. The study aims to include those who could benefit from improved hemostasis methods post-procedure.

Inclusion Criteria

I am referred for a heart exam through my wrist artery.

Ability to provide written informed consent

I am 18 years old or older.

Exclusion Criteria

I am on long-term blood thinners for another health issue.

Patients requiring greater than 6 French catheter access

I need more than 50 units/kg of heparin for medical procedures.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo trans-radial cardiac catheterization with either standard or reduced heparin dose and specific compression protocols

1 day

1 visit (in-person)

Follow-up

Participants are monitored for radial artery occlusion, hematoma formation, and rebound bleeding post-procedure

24 hours

1 visit (in-person)

Treatment Details

Interventions

• Heparin (Anticoagulant)

Trial Overview The SAFE & FAST Trial is testing whether a combination of lower-dose heparin and two different radial compression devices (Terumo Radial Band and Vaosband) can reduce problems like artery blockage and bleeding after wrist-access heart procedures.

Participant Groups

Group I: Group 2-Low dose heparin Experimental Treatment 2 Interventions

Patients in this arm will be labeled as Group 2. Patients will receive a reduced heparin dose (25 U/Kg) and a compression time of 60 minutes using the VASOBand™, with simultaneous ipsilateral ulnar artery compression.

Group II: Group 1-Regular dose heparin Active Control 2 Interventions

Patients in this arm will be labeled as Group 1. Patients will receive a standard heparin dose (50U/Kg) with a total compression time of 2 hours using the TR band ®.

Heparin is already approved in Canada for the following indications:

Approved in Canada as Heparin sodium for:

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Regional Hospital of Scranton Scranton, PA

Who Is Running the Clinical Trial?

Regional Hospital of Scranton

Lead Sponsor

Trials

2

Patients Recruited

450+

Findings from Research

Intermittent flushing of peripheral venous catheters with 10 U/ml of heparin did not improve catheter patency or reduce complications compared to normal saline.

Continuous infusion of low-dose heparin (1 U/ml) significantly decreased the risk of phlebitis and prolonged the duration of patency for both peripheral arterial and venous catheters, indicating its potential benefit in maintaining catheter function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit of heparin in peripheral venous and arterial catheters: systematic review and meta-analysis of randomised controlled trials. Randolph, AG., Cook, DJ., Gonzales, CA., et al.[2019]

Unfractionated heparin (UFH) is a long-established anticoagulant that is still commonly used for treating venous thromboembolism (VTE) and other related conditions, demonstrating its continued relevance in clinical practice.

Despite its extensive use over nearly a century, there are still important questions about the best dosing and monitoring practices for UFH that need further investigation to optimize its effectiveness and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unfractionated heparin for the treatment of venous thromboembolism: best practices and areas of uncertainty. Cuker, A.[2012]

Enoxaparin was found to be more effective than unfractionated heparin (UFH) in reducing the combined risk of death, myocardial infarction, and urgent revascularization in both obese and non-obese patients, as well as those without severe renal impairment.

Patients with severe renal impairment showed a higher risk of adverse clinical events and major hemorrhages, indicating that while enoxaparin is effective, this population may require closer monitoring due to increased risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of unfractionated heparin versus enoxaparin in patients who are obese and patients with severe renal impairment: analysis from the ESSENCE and TIMI 11B studies. Spinler, SA., Inverso, SM., Cohen, M., et al.[2014]

In a study of 200 patients with non-ST-elevation acute coronary syndrome, those receiving unfractionated heparin in dextrose 5% in water (UFH-D5W) achieved therapeutic anti-factor Xa levels within 24 hours 92% of the time, compared to only 67% for those receiving unfractionated heparin in normal saline (UFH-NS).

UFH-NS was associated with a significantly lower likelihood of achieving and maintaining therapeutic anticoagulation, requiring more adjustments to the infusion rate, indicating that UFH-D5W is the more effective preparation for anticoagulation in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Unfractionated Heparin in Normal Saline versus Dextrose for Achieving and Maintaining Therapeutic Anti-Factor Xa Levels in Patients with Non-ST-Elevation Acute Coronary Syndrome. Jacques, AC., Lougheed, C., Macdonald, E., et al.[2021]

References

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

Enoxaparin versus unfractioned heparin as anticoagulant for continuous venovenous hemodialysis: a randomized open-label trial. [2010]

2. United States pubmed.ncbi.nlm.nih.gov

Heparin or enoxaparin anticoagulation for primary percutaneous coronary intervention. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Benefit of heparin in peripheral venous and arterial catheters: systematic review and meta-analysis of randomised controlled trials. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of 2 weight-based heparin dosing nomograms in neurology and vascular surgical patients. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Unfractionated heparin for the treatment of venous thromboembolism: best practices and areas of uncertainty. [2012]

6. United States pubmed.ncbi.nlm.nih.gov

Unfractionated heparin: focus on a high-alert drug. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of unfractionated heparin versus enoxaparin in patients who are obese and patients with severe renal impairment: analysis from the ESSENCE and TIMI 11B studies. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Unfractionated heparin for hemodialysis: still the best option. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of Unfractionated Heparin in Normal Saline versus Dextrose for Achieving and Maintaining Therapeutic Anti-Factor Xa Levels in Patients with Non-ST-Elevation Acute Coronary Syndrome. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Acid-citrate-dextrose Formula A versus heparin as primary catheter lock solutions for therapeutic apheresis. [2016]