Combination Strategies for Catheter Complications

Recruiting at 1 trial location

Overseen By Khyati Khattar, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Regional Hospital of Scranton

Must not be taking: Anticoagulants

Disqualifiers: No consent, High heparin dose, others

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

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests methods to make the transradial approach (TRA), a common heart procedure, safer and faster. It examines different doses of the blood thinner heparin (also known as Heparin sodium or Unfractionated heparin) to determine if they can reduce bleeding and shorten the time needed for artery compression afterward. One group will receive a regular heparin dose, while another will receive a lower dose combined with a special compression method. Individuals undergoing cardiac catheterization through the wrist who can provide consent are suitable for this study. As an unphased trial, this study allows participants to contribute to enhancing the safety and efficiency of heart procedures.

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 prior data suggests that these combination strategies are safe for reducing catheter complications?

Research has shown that low-dose heparin is generally safe for patients. Studies indicate that it might cause a slight increase in bruising around wounds, but any additional bleeding is minimal and not significant. Comparisons between high-dose and low-dose heparin revealed no major differences in safety, particularly concerning bleeding or clotting. Thus, low-dose heparin is well-tolerated and as safe as the standard doses used in many procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these methods for managing catheter complications because they explore how different doses of heparin and compression techniques could optimize patient outcomes. Currently, catheter-related issues are often managed using standard doses of heparin and prolonged compression times. Group 1 follows a traditional approach with a regular heparin dose and extended compression time. However, Group 2 stands out by using a lower heparin dose and shorter compression time, incorporating the innovative VASOBand™ and ipsilateral ulnar artery compression. This could potentially reduce bleeding risks and improve patient comfort, offering a fresh perspective on catheter care.

What evidence suggests that this trial's treatments could be effective for reducing catheter complications?

In this trial, participants will divide into two groups to evaluate different dosing strategies of heparin. Group 1 will receive a regular dose, while Group 2 will receive a low dose. Previous studies have found that low-dose heparin can be as effective as regular or high doses in keeping catheters clear and open, preventing blockages with minimal drug use. Although low-dose heparin does not reduce major bleeding or complications at the access site, it still helps maintain catheter function. Additionally, it tends to cause fewer side effects, such as bleeding, compared to higher doses, making it a safer choice for some patients. This suggests that using less heparin might effectively reduce complications after certain heart procedures. ^{1 2 3 5 6}

Who Is on the Research Team?

Nishant Sethi, MD

Principal Investigator

Regional Hospital of Scranton

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Heparin

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.

How Is the Trial Designed?

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 European Union, United States, Canada for the following indications:

Approved in European Union as Heparin sodium for:

• Prevention of thromboembolic disorders
• Treatment of deep vein thrombosis
• Treatment of pulmonary embolism
• Prevention of clotting in extracorporeal circuits

Approved in United States as Heparin sodium for:

• Prevention and treatment of deep vein thrombosis and pulmonary embolism
• Prevention of postoperative deep vein thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery
• Atrial fibrillation with embolization
• Treatment of acute and chronic consumptive coagulopathy

Approved in Canada as Heparin sodium for:

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

Who Is Running the Clinical Trial?

Regional Hospital of Scranton

Lead Sponsor

Trials

2

Recruited

450+

Published Research Related to This Trial

Unfractionated heparin (UFH) is a high-alert medication with a significant risk of drug-related problems, including harmful medication errors that account for 4.5-5.5% of reported cases, highlighting the need for improved safety measures in its administration.

UFH therapy can lead to serious complications such as heparin-induced thrombocytopenia, bleeding events, and osteopenia, with safer alternatives like low-molecular-weight heparins offering equivalent or superior efficacy for many conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unfractionated heparin: focus on a high-alert drug. Niccolai, CS., Hicks, RW., Oertel, L., et al.[2019]

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]

Unfractionated heparin (UFH) is the preferred anticoagulant for maintenance hemodialysis in the U.S. due to its ease of use, safety, and low cost, despite low molecular weight heparin (LMWH) being more common in Europe.

Both UFH and LMWH can cause side effects like heparin-induced thrombocytopenia and hyperkalemia, and alternative anticoagulation methods are recommended when UFH is contraindicated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unfractionated heparin for hemodialysis: still the best option. Cronin, RE., Reilly, RF.[2022]

In a study of 580 patients undergoing percutaneous coronary intervention (PCI) for STEMI, enoxaparin was found to be more effective than unfractionated heparin (UFH) in reducing the risk of death and recurrent myocardial infarction, both during hospitalization and up to 30 days post-procedure.

Patients receiving enoxaparin were more likely to achieve therapeutic anticoagulation during the procedure without an increase in major bleeding events, suggesting it is a safer and more effective option for anticoagulation in STEMI patients undergoing PCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heparin or enoxaparin anticoagulation for primary percutaneous coronary intervention. Brieger, D., Collet, JP., Silvain, J., et al.[2022]

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]

In a study of 40 patients with acute renal failure undergoing continuous venovenous hemodialysis, enoxaparin was associated with a higher rate of minor bleeding compared to unfractionated heparin (26% vs. 0%).

Both enoxaparin and unfractionated heparin showed similar effectiveness in maintaining dialysis circuit function, indicating that unfractionated heparin remains a safe and cost-effective option for anticoagulation in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enoxaparin versus unfractioned heparin as anticoagulant for continuous venovenous hemodialysis: a randomized open-label trial. Garcés, EO., Victorino, JA., Thomé, FS., et al.[2010]

A higher weight-based dosing strategy for unfractionated heparin (UFH), using an 80-unit/kg bolus and an 18-unit/kg/h infusion rate, achieved therapeutic anticoagulation more quickly than a lower dosing strategy (60-unit/kg bolus and 12-unit/kg/h infusion) in a study of 98 patients.

At 6 hours, 36% of patients in the higher dose group were within the therapeutic range for activated partial thromboplastin time (aPTT), compared to only 16.7% in the lower dose group, indicating that the higher dose not only improved efficacy but also reduced the number of patients with subtherapeutic aPTTs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 2 weight-based heparin dosing nomograms in neurology and vascular surgical patients. Marotti, SB., Barras, M., Kirkpatrick, C.[2015]

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]

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]

In a study analyzing 5964 catheter days across 3020 procedures, both unfractionated heparin (UFH) and Acid-citrate-dextrose Formula A (ACD-A) were found to be equally effective for short-term catheter use, with differences in outcomes being minimal (less than 5.3%).

However, for long-term catheter use, UFH demonstrated superior efficacy compared to ACD-A, suggesting that while ACD-A is a reasonable alternative for short-term applications, UFH may be preferred for longer durations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acid-citrate-dextrose Formula A versus heparin as primary catheter lock solutions for therapeutic apheresis. Osby, M., Barton, P., Lam, CN., et al.[2016]

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Heparin - StatPearls - NCBI Bookshelf

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Low-dose compared with standard-dose unfractionated heparin did not reduce major peri-PCI bleeding and vascular access-site complications.

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jthjournal.org

jthjournal.org/article/S1538-7836(22)07485-2/fulltext

comparison of high‐dose vs. low‐dose heparin protocols

Results: A total of 227 children were included; 137 were randomized and 90 followed in the cohort study. The overall incidence of TE was 4.6% and bleeding 6.6%.

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ahajournals.org

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

Guide to Anticoagulant Therapy: Heparin | Circulation

The use of low-dose heparin is associated with a small excess incidence of wound hematoma and a minimal, statistically insignificant increase in major bleeding ...

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Heparin dose during percutaneous coronary intervention

... low dose heparin (70 U/kg). They demonstrated reduction in death ... Safety of low dose heparin in elective coronary angioplasty. Heart 1997;77 ...