Injectable Medication Platforms for Medical Treatments
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.12345Why 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.678910
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Experimental Injection Scenarios
Participants administer injections using various methods: standard protocol, autoinjector, and pre-filled syringes.
Follow-up
Participants are monitored for any injection failures, injuries, and perceived difficulty of injection methods.
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?
1
Treatment groups
Experimental Treatment
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Canadian Forces Health Services Centre Ottawa
Lead Sponsor
Citations
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.
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-emergenciesNew 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 ...
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 ...
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.pdfSafety 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.pdfSAFETY 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.pdfEpinephrine 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.pdfAUVI-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_toaOKAGQtY18mTd14xinwEpinephrine (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.
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