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TXA for Bleeding in Liver Surgery (HeLiX Trial)
HeLiX Trial Summary
This trial will evaluate the impact of tranexamic acid on perioperative blood transfusion in patients undergoing liver resection. TXA is given to help prevent or treat excessive bleeding. The study will enroll 1230 participants.
HeLiX Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowHeLiX Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.HeLiX Trial Design
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Who is running the clinical trial?
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- You are allergic to TXA or any of the ingredients in it.I haven't taken any blood thinners, except for low doses to prevent clots, in the last week.I have a history of seizures.I have a condition that affects my blood's ability to clot.I have been diagnosed with a cancer-related condition.My kidneys are not working well (low creatinine clearance).I am scheduled for liver surgery, either open or with a camera.I am 18 years old or older.I cannot receive blood products due to past severe reactions or personal reasons.I have recently developed problems with seeing colors.
- Group 1: Tranexamic acid (TXA)
- Group 2: Normal saline (0.9% sodium chloride)
- 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
Are people enrolling in this experiment right now?
"Unfortunately, this particular study has stopped recruiting patients. The trial was first announced on November 1st, 2014 but was last updated on October 25th, 2022. However, there are presently 1140 trials actively admitting patients with malignancies and 175 trials for Tranexamic acid (TXA) actively enrolling patients."
Does Tranexamic acid (TXA) have any negative side effects for patients?
"While Phase 3 trials are not the final stage of testing, they are critical in that they provide efficacy data as well as multiple rounds of data supporting safety. Based on this, our team at Power has rated Tranexamic acid (TXA) as a 3 in terms of safety."
How many different places are coordinating this clinical trial?
"Patients are being accepted at several institutions across North America, including but not limited to McGill University Health Centre in Montreal, Quebec, Sunnybrook Health Sciences Centre in Toronto, Alberta, and Kingston General Health Research Institute in Kingston, Minnesota."
What are some of the most common reasons that Tranexamic acid (TXA) is given to patients?
"While most commonly used to treat diarrhea, Tranexamic acid (TXA) can also be employed in the treatment of general surgery, urine alkalinization therapy, and sodium depletion."
Could you please provide an overview of other research projects that have used Tranexamic acid (TXA)?
"At the moment, 175 clinical trials are underway to research Tranexamic acid (TXA). Out of these, 57 are in Phase 3. Calgary, Alberta has a high concentration of these trials, with 57 total, but Tranexamic acid (TXA) trials are happening in 665 locations worldwide."
How many people suffering from this disease have been given the chance to try this treatment?
"Unfortunately, this trial is not currently recruiting patients. Although, it's worth noting that the trial was last updated on 10/25/2022. If you're interested in other studies, there are 1140 clinical trials for cancer patients and 175 trials for Tranexamic acid (TXA) that are presently active."
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