Injectable Medication Platforms for Medical Treatments

Overseen By Sean Meredith, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Canadian Forces Health Services Centre Ottawa

Disqualifiers: Cognitive impairment, Manual dexterity issues, Substance use, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test different methods for quickly injecting medications during emergencies such as severe allergic reactions, seizures, overdoses, or heavy bleeding. Participants will practice using various injection methods, including autoinjectors, prefilled syringes, and standard injectors, to determine which is the fastest and most effective. The trial seeks individuals who have not injected medications in the past year and do not have cognitive or manual dexterity issues. As an unphased trial, it offers participants the chance to contribute to enhancing emergency medical responses.

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

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

What prior data suggests that these injectable medication platforms are safe?

Research has shown that autoinjectors, prefilled syringes, and standard injectors are safe to use. Studies confirm that autoinjectors meet U.S. safety standards and are not considered dangerous. Guidelines for safe handling, such as wearing protective gear, mainly apply to occupational use.

Prefilled syringes also have a strong safety record. They are not seen as hazardous, and no special precautions are needed for storage. However, prolonged skin contact may cause irritation, so handling with care is advisable.

Standard injectors are generally safe and aid in accurate dosing. If any material contacts the skin, washing with soap and water is sufficient.

Overall, these injection methods are well-tolerated, with very few side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to deliver life-saving medications like Naloxone, Epinephrine, and Tranexamic Acid. Unlike traditional methods, which often involve drawing medication from a vial and using a syringe, this trial examines newer platforms like autoinjectors and prefilled syringes. These methods could simplify the process and make it faster and more convenient, especially in emergencies. By comparing these different delivery methods, researchers hope to find out which is most effective and user-friendly, potentially improving outcomes in urgent medical situations.

What evidence suggests that this trial's injectable medication platforms could be effective for medical emergencies?

This trial will compare different injectable medication platforms, including autoinjectors, prefilled syringes, and standard injectors. Research has shown that autoinjectors effectively deliver medications quickly during emergencies. For example, tranexamic acid (TXA) delivered with an autoinjector reaches the needed level in less than five minutes, which is crucial for stopping severe bleeding. Prefilled syringes also show promise by speeding up medication delivery and improving safety compared to drawing medicine from vials. Studies confirm that prefilled systems are more efficient and can reduce the time needed to administer life-saving drugs. Standard injectors work well too, but they might take longer to prepare and use, which can be a drawback in urgent situations. Overall, strong evidence supports the effectiveness of these different injection methods in emergency care. ^{6 7 8 9 10}

Who Is on the Research Team?

Gaurav Gupta, MD

Principal Investigator

CAF

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can consent and have not used medication injections in the past year. It's not for healthcare workers with recent injection experience or those with conditions affecting thinking or hand coordination, as well as anyone with recent substance use.

Exclusion Criteria

Recent substance use

Participants with pre-specified conditions impacting cognitive and/or manual dexterity

I have given myself or someone else an injection in the past year, and I am not a healthcare worker.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Injection Scenarios

Participants administer injections using various methods: standard protocol, autoinjector, and pre-filled syringes.

1-2 weeks

Multiple sessions (in-person)

Follow-up

Participants are monitored for any injection failures, injuries, and perceived difficulty of injection methods.

immediately after intervention

What Are the Treatments Tested in This Trial?

Interventions

• Assessment of Injectable Medication Platforms
• Autoinjector
• Prefilled
• Standard Injector

Trial Overview The study compares different methods of injecting emergency medications: autoinjectors, standard injectors, and prefilled syringes. The goal is to find out which method delivers medicine most efficiently during emergencies like severe allergies or overdoses.

How Is the Trial Designed?

Group I: Injection Scenario Experimental Treatment 3 Interventions

For each scenario participants will be asked to administer/inject the "medication" (likely saline or air) using various methods: 1) standard protocol , 2) Autoinjector 3) Pre-filled syringes. For each scenario the appropriate medication administration type will have to be selected amongst groups of options: 1) autoinjectors equivalents (ie medication, needle and syringe attached) 2) prefilled syringes where a needle is attached prior to administration; and 3) standard protocol (i.e. drawing medication from the vial and injecting via syringe/22 gauge needle). Medications options will include 1) Naloxone (opioid overdose) 2) Epinephrine (anaphylaxis) 3) Tranexamic acid (bleeding).

Who Is Running the Clinical Trial?

Canadian Forces Health Services Centre Ottawa

Lead Sponsor

Trials

10

Recruited

1,200+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0020138325005790

Autoinjector-based delivery of tranexamic acid provides ... The animals treated with the autoinjector in this study were hemodynamically stable to the same degree as animals in the IV group.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12468126/

Effectiveness and Safety of Topically Applied Tranexamic Acid ... In Group I, TXA + epinephrine significantly reduced blood loss (35.4 vs. 53.5 mL) and improved field visibility compared to epinephrine alone.

3. manufacturingchemist.com manufacturingchemist.com/new-txa-autoinjector-save-lives-severe-bleeding-emergencies

New TXA autoinjector could save lives in severe bleeding ... In this new study, the researchers found that TXA delivered via autoinjector reached effective therapeutic levels in less than five minutes and ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40915868/

Autoinjector-based delivery of tranexamic acid provides ... Results: The TXA levels in the autoinjector group exceeded the effective therapeutic threshold within <5 min and remained above the 10 mg/L ...

5. api.army.mil api.army.mil/e2/c/downloads/2025/07/16/bb8f39d2/no-25-1039-the-role-of-tranexamic-acid-in-future-combat-casualty-care-jul-25.pdf

The Role of Tranexamic Acid in Future Combat Casualty ... The study aimed to determine if early TXA administration by combat medics could reduce mortality in injured military personnel. The MATTERS ...

6. purduepharma.com purduepharma.com/wp-content/uploads/2025/01/Zurnai-nalmefene-injection-1.5-mg-in-0.5-mL-Auto-Injector-SDS.pdf

Safety Data Sheet Zurnai™ 1.5 mg/0.5 mL Auto-Injector P280 Wear protective gloves, eye protection, and face protection. P284 In case of inadequate ventilation, wear respiratory protection. Page 2 ...

7. novonordiskmedical.com novonordiskmedical.com/content/dam/medical/novonordiskmedical/documents/safety-data-sheets/zegalogue-sds-autoinjector-october-2022.pdf

SAFETY DATA SHEET - Novo Nordisk Medical This material is not classified as hazardous under U.S. OSHA regulations (29 CFR 1910.1200) (Hazcom 2012) and. Canadian WHMIS regulations ( ...

8. pfe-pfizercom-prod.s3.amazonaws.com pfe-pfizercom-prod.s3.amazonaws.com/products/material_safety_data/Epinephrine_injection%28hospira%29_3-Noc-2016_0.pdf

Epinephrine Injection (Hospira, Inc.) - SAFETY DATA SHEET Signal Word: Not Classified. Hazard Statements: Not classified in accordance with international standards for workplace safety. Other Hazards. An Occupational ...

9. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_KALEOI_AUVI_Q_AUTO_INJECT_0.3MG_0.3ML_2025.pdf

AUVI-QTM (epinephrine injection, USP) 0.3 mg or 0.15 ... 7.1 Precautions for Safe Handling​​ Use with adequate ventilation. Avoid contact with eyes, skin and clothing.

10. schoolhealth.com schoolhealth.com/media/pdf/1037709%20MSD_SDSD.pdf?srsltid=AfmBOoptUfBEb-Dy1EB04gFMWPbeDDGUvE_toaOKAGQtY18mTd14xinw

Epinephrine (EpiPen® and EpiPen Jr®) Auto-Injector The intent of this safety data sheet (SDS) is to provide safety information for occupational handling of this product.