Quantra QPlus in Pediatric Cardiovascular Procedures
14 september 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
160
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Deborah Winegar
- Telefonnummer: 9192446990
- E-post: dwinegar@hemosonics.com
Studieorter
-
-
California
-
Los Angeles, California, Förenta staterna, 90095
- UCLA Mattel Children's Hospital
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna, 30329
- Children's Healthcare of Atlanta
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Förenta staterna, 19104
- Children's Hospital of Philadelphia
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
The study population includes pediatric patients <18 years of age that are undergoing cardiovascular procedures.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Correlation of QPlus CT measurements to ROTEM Sigma INTEM CT
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
25 juni 2027
Primärt slutförande (Beräknad)
1 juni 2028
Avslutad studie (Beräknad)
15 oktober 2028
Studieregistreringsdatum
Först inskickad
12 maj 2026
Först inskickad som uppfyllde QC-kriterierna
15 maj 2026
Första postat (Faktisk)
19 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HEMCS-051
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Data sharing agreements prevent sharing of IPD.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Ja
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