An observational study in Blood Loss, Surgical, sponsored by HemoSonics LLC. Not yet recruiting at 3 sites in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by HemoSonics LLC (part of Stago) · Observational
This study will evaluate the performance of the Quantra System with the QPlus Cartridge in pediatric patients undergoing cardiovascular procedures.
Pediatric patients that require major sugical procedures, such as cardiac surgery, are especially vulnerable to perioperative coagulopathy due to age-related immaturity of the hemostatic system, exposure to hemodilution from circuit primes or intravenous volume loading, hypothermia during complex interventions, and the intrinsic bleeding of invasive cardiac procedures. These factors can produce clinically significant perioperative bleeding driven by platelet dysfunction, hypofibrinogenemia and other hemostatic defects. The Quantra System with the QPlus Cartridge is desinged to assess coagulation function of a whole blood sample at the point-of-care by measuring changes in the viscoelastic properties during clot formation. This multi-center study is aimed to demonstrate the performance of the QPlus Cartridge for its ability to aid in the evaluation of a pediatric patient's hemostatic status before, during and after cardiovascular procedures.
213 studies on the registry are indexed under Blood Loss, Surgical; 40 are open to participants now.
This study's planned enrollment of 160 is close to the median of 154 across 43 observational studies indexed under Blood Loss, Surgical.
Browse Blood Loss, Surgical studies →HemoSonics LLC is the lead sponsor of 26 studies on the registry; 2 are open to participants now.
First submitted after HemoSonics LLC became part of Stago.
Counted across the registry records on this site, refreshed daily.
The study population includes pediatric patients \<18 years of age that are undergoing cardiovascular procedures.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pediatric patients undergoing cardiovascular procedures
Diagnostic Test: Quantra System
Diagnostic device to monitor the coagulation properties of a whole blood sample at the point-of-care.
Correlation of QPlus CT measurements to ROTEM Sigma INTEM CT
Coagulation function assessed by Quantra and ROTEM sigma
Time frame: 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
Coagulation function assessed by Quantra and ROTEM sigma
Time frame: 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
Coagulation function assessed by Quantra and ROTEM sigma
Time frame: 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
Coagulation function assessed by Quantra and ROTEM sigma
Time frame: 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
Coagulation function assessed by Quantra and TEG 6S
Time frame: 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
Coagulation function assessed by Quantra and TEG 6S
Time frame: 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 to TEG 6S CKH-MA
Coagulation function assessed by Quantra and TEG 6S
Time frame: 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 to TEG 6S FFH-MA
Coagulation function assessed by Quantra and TEG 6S
Time frame: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Plan to share: No — Data sharing agreements prevent sharing of IPD.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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