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Cold Stored Platelets for Hemorrhagic Shock (CriSP-HS Trial)
CriSP-HS Trial Summary
This trial is designed to study the feasibility, efficacy, and safety of using cold stored platelets to treat patients in hemorrhagic shock.
- Bleeding
- Trauma
CriSP-HS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CriSP-HS Trial Design
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Who is running the clinical trial?
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- You only fell from a standing position and were not involved in any other type of injury.You have burns that cover more than 20% of your body.You have two or more of the following:You experienced a traumatic event where your heart stopped beating for more than 5 minutes despite attempts to revive you.You have a serious head injury, like a gunshot wound, where the brain is damaged or penetrated.You have experienced a drowning or hanging incident, but there were no other significant injuries or complications.You have recently experienced a serious injury that meets certain specific conditions.Your heart rate is very fast, over 120 beats per minute, when measured before arriving at the hospital or in the emergency room.Your blood pressure is very low (less than 90 mmHg).You have a history of being injured by a sharp object penetrating your skin.
- Group 1: Cold-stored Platelet (CSP)
- Group 2: Standard Care
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 participants has this clinical trial attracted?
"Accurate. Clinicaltrials.gov states that this research project, which was initially posted on June 21st 2022, is still seeking participants. 200 individuals need to be enrolled at 5 various medical sites."
Is there an opportunity for me to partake in this clinical experiment?
"This study needs to enroll 200 patients aged 15-90 who are currently suffering from hemorrhage. In order for potential participants to qualify, they must have a Focused Assessment with Sonography for Trauma (FAST) abdominal ultrasound that is positive or equivocal or deferred by clinical team due to an emergency visit, heart rate greater than 120 in the prehospital or emergency department setting, and a penetrating mechanism. It is also required that there be need of Operating Room intervention (laparotomy, thoracotomy or vascular exploration) within 60 minutes of arrival at facility."
Could you elucidate the potential risks associated with Cold Stored Platelets (CSP) for patients?
"The safety of Cold Stored Platelets (CSP) has been awarded a rating of 2 due to the lack of supporting evidence for efficacy and some data that suggests its safety within this Phase 2 clinical trial."
How many venues are overseeing this scientific investigation?
"There are presently 5 sites taking part in this medical trial, based out of San Francisco, Jackson and Los Angeles plus a further 5 locations. To minimize the amount of travel required to attend study appointments it is best to select the site closest you."
Is this trial currently open for enrollment?
"According to the details available on clinicaltrials.gov, this medical trial is currently searching for participants and was first made public on June 21st 2022 with its latest edit taking place a week later."
Does the research allow for participants aged eighty or above?
"According to the entry requirements of this clinical trial, potential participants must be aged 15-90. There are 64 studies available for minors and 336 specifically tailored towards seniors."
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