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NCT05295693
Quantra vs TEG for Congenital Cardiac Surgery - a Pilot Validation Study
trial testing Correlation of the Quantra with the TEG in Coagulopathy in 40 participants. Completed in 25 May 2023.
25 May 2023
Quick facts
| Lead sponsor | Stanford University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 40 |
| Start date | 13 October 2022 |
| Primary completion | 25 May 2023 |
| Estimated completion | 25 May 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Correlation of the Quantra with the TEG
Conditions studied
- Coagulopathy — all drugs for Coagulopathy →
Sponsor
Stanford University
Who can join
Under 8, any sex, with Coagulopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Congenital heart surgery on cardio-pulmonary bypass (CPB) is associated with impacted coagulation quality and increased bleeding after separation of CPB. The current testing device used at our institution is the "TEG 5000" (Haemonetics Corporation). The novel coagulation testing device "Quantra System" (Hemosonics) has favorable properties (result within 20 minutes) allowing for a quicker identification of the coagulation problem and hence faster administration of the correct coagulation products, potentially leading to better coagulation quality and possibly reducing the need of additional blood products. The aim of this prospective observational (non-interventional, investigational only) quality improvement study is to investigate if the Quantra is reliable and valid in predicting the coagulation status when compared with our standard-of-care device TEG 5000.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05295693
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05295693 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Stanford University
- Last refreshed: 13 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05295693.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing