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Cold vs Room Temperature Platelet Transfusions for Cardiac Surgery Patients (CHIPS Trial)
CHIPS Trial Summary
This trial will compare the transfusion of cold stored platelets to standard room temperature stored platelets in patients undergoing complex cardiac surgery. The primary objective is to establish that cold stored platelets are at least as good as room temperature platelets.
CHIPS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCHIPS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CHIPS Trial Design
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- My platelet count is below 75,000 based on recent tests before surgery.I am scheduled for ECMO, VAD, or dialysis after surgery.I have not had a platelet transfusion in the 24 hours before my surgery date.I am scheduled for a complex heart surgery that will use a heart-lung machine.I am expected to receive a blood transfusion during or after surgery due to bleeding.I have a genetic disorder affecting my platelets.I am older than 28 days and younger than 85 years.I refuse to receive blood products.I have a hereditary bleeding disorder.
- Group 1: Room Temperature Platelets
- Group 2: Cold Stored Platelets
- 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
Is this study limited to a certain age group?
"For this particular trial, only those aged 29 days to 84 years qualify as participants. Out of the total 365 ongoing clinical trials, 57 are for those under 18 years old and 308 are for those over 65."
Who is this clinical study meant for?
"This study is currently looking for 1000 individuals, aged between 29 days and 84 years old, who have acute coryza and meet the additional surgical requirements."
How many study participants will be enrolled in total?
"In order to acquire the desired data, this clinical study needs to enroll 1000 willing and eligible patients. Luckily, there are many locations across the country that are participating in this trial, such as University of Michigan in Ann Arbor, Michigan and University of Florida in Gainesville, Florida."
Do we have the green light from the FDA to use Cold Stored Platelets?
"Cold Stored Platelets have received a 3 for safety because this clinical trial is a Phase 3. That means there is available data that supports efficacy as well as multiple rounds of data that support safety."
Could you inform me as to how many hospitals are participating in this research?
"There are a total of 17 sites where this study is being conducted. The locations are listed on the website and include Ann Arbor, Gainesville, and Dallas. Patients are encouraged to pick the site that is closest to them to reduce travel time and complications."
Is this research study still enrolling new participants?
"As can be seen on clinicaltrials.gov, this research is still recruiting volunteers. The trial was first advertised on 2021-10-21 and the most recent update was on 2022-10-05."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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