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Study Summary
This trial will test how safe and effective a new medical product is at controlling bleeding during surgery in children.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 3 trial • 102 Patients • NCT01993888Trial Design
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- You are able to press the trial treatment firmly for at least 4 minutes after it is applied.I cannot tolerate blood products or components of the study product.I am a woman of childbearing age and I am not pregnant or nursing.I have been or will be vaccinated for COVID-19 around my surgery.I have large artery or vein injuries needing repair while keeping the blood vessel open.I have had major bleeding that needed stitches or a procedure to stop it.I am admitted for surgery due to an injury.My surgeon found issues that might stop me from being part of the study.My wound is severely infected.I am a baby aged between 28 days and less than 1 year.I am under 18 and need surgery that is not an emergency on my liver, abdomen, pelvis, or chest.My surgeon identified a suitable bleeding site during surgery.I am under 18 years old and among the first 31 to join.You are currently using alcohol or drugs excessively.My bleeding is near or in a bone area.
- Group 1: EVARREST® Fibrin Sealant Patch
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many people can enroll in this clinical trial at the most?
"That is correct. The clinicaltrials.gov website has the most recent information on this study, which was last edited on 10/31/2022. The trial is looking for 35 patients from 1 site."
If a patient is a minor, can they still qualify for this research project?
"This particular clinical trial is only for patients that are 28 days to 17 years old. Out of the 61 clinical trials that are for patients under 18, this is one of them. For patients over 65, there are 323 clinical trials."
What is the EVARREST® Fibrin Sealant Patch most effective in mending?
"EVARREST® Fibrin Sealant Patch is frequently used to treat fibrinogen deficiency. However, it has also shown efficacy in other areas such as hemostasis, myringoplasty, and hemorrhage."
Does EVARREST® Fibrin Sealant Patch have any negative side effects?
"EVARREST® Fibrin Sealant Patch is in Phase 3 clinical trials, so there is some evidence of its efficacy and it has undergone multiple rounds of safety testing. Therefore, our team rates its safety as a 3."
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