Not Yet RecruitingNot Applicable

Quantra QPlus in Pediatric Cardiovascular Procedures

United States160 participantsStarted 2026-09-25

Plain-language summary

This study will evaluate the performance of the Quantra System with the QPlus Cartridge in pediatric patients undergoing cardiovascular procedures.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject is \<18 years of age. * Subject is undergoing a cardiovascular procedure OR subject underwent cardiovascular surgery and presents with acute bleeding or suspected hypocoagulation/hypercoagulation in a post-surgical unit. * Subject's parent(s) or guardian(s) has signed an informed consent form. If required, subject has signed an assent form. Exclusion Criteria: * Corrected gestational age \<37 weeks. * Subject is enrolled in a study that might confound the result of the proposed study. * Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Correlation of QPlus CT measurements to ROTEM Sigma INTEM CT

Timeframe: 3 TIme Points: 1. 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.

Correlation of QPlus CTH measurements to ROTEM Sigma HEPTEM CT

Timeframe: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.

Correlation of QPlus CS measurements to ROTEM Sigma EXTEM A10

Timeframe: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.

Correlation of QPlus FCS measurements to ROTEM Sigma FIBTEM A10

Timeframe: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.

Correlation of QPlus CT to TEG 6S CK-R

Timeframe: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.

Correlation of QPlus CTH to TEG 6S CKH-R

Timeframe: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.

Trial details

NCT IDNCT07597278

SponsorHemoSonics LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-08-31

Contact for this trial

Deborah Winegar

9192446990 dwinegar@hemosonics.com

View on ClinicalTrials.gov More Blood Loss, Surgical trials