Quantra QPlus in Pediatric Cardiovascular Procedures
14. september 2026 oppdatert av: HemoSonics LLC
Evaluation of the Clinical Performance of the Quantra System With the QPlus Cartridge in Pediatric Patients Undergoing Cardiovascular Procedures
This study will evaluate the performance of the Quantra System with the QPlus Cartridge in pediatric patients undergoing cardiovascular procedures.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
160
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Deborah Winegar
- Telefonnummer: 9192446990
- E-post: dwinegar@hemosonics.com
Studiesteder
-
-
California
-
Los Angeles, California, Forente stater, 90095
- UCLA Mattel Children's Hospital
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30329
- Children's Healthcare of Atlanta
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater, 19104
- Children's Hospital of Philadelphia
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
The study population includes pediatric patients <18 years of age that are undergoing cardiovascular procedures.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Pediatric patients
Pediatric patients undergoing cardiovascular procedures
|
Diagnostic device to monitor the coagulation properties of a whole blood sample at the point-of-care.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation of QPlus CT measurements to ROTEM Sigma INTEM CT
Tidsramme: 3 TIme Points: 1. 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
|
Coagulation function assessed by Quantra and ROTEM sigma
|
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
Tidsramme: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
|
Coagulation function assessed by Quantra and ROTEM sigma
|
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
Tidsramme: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
|
Coagulation function assessed by Quantra and ROTEM sigma
|
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
Tidsramme: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
|
Coagulation function assessed by Quantra and ROTEM sigma
|
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
Tidsramme: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
|
Coagulation function assessed by Quantra and TEG 6S
|
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
Tidsramme: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
|
Coagulation function assessed by Quantra and TEG 6S
|
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
Tidsramme: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
|
Coagulation function assessed by Quantra and TEG 6S
|
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
Tidsramme: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
|
Coagulation function assessed by Quantra and TEG 6S
|
3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
25. juni 2027
Primær fullføring (Antatt)
1. juni 2028
Studiet fullført (Antatt)
15. oktober 2028
Datoer for studieregistrering
Først innsendt
12. mai 2026
Først innsendt som oppfylte QC-kriteriene
15. mai 2026
Først lagt ut (Faktiske)
19. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HEMCS-051
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Data sharing agreements prevent sharing of IPD.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Ja
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