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NCT03699813
ROTEM Versus aPTT/PT in Pediatric Surgery
trial testing Comparison of two approaches to bleeding management in Coagulation Defect; Bleeding in 45 participants. Completed in 15 September 2018.
15 September 2018
Quick facts
| Lead sponsor | University Hospital, Motol |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 45 |
| Start date | 2 February 2015 |
| Primary completion | 15 September 2018 |
| Estimated completion | 15 September 2018 |
Drugs / interventions tested
- Comparison of two approaches to bleeding management
Conditions studied
- Coagulation Defect; Bleeding — all drugs for Coagulation Defect; Bleeding →
Sponsor
University Hospital, Motol
Who can join
Adults 5 to 18, any sex, with Coagulation Defect; Bleeding. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hemocoagulation management in perioperative bleeding is nowadays based on standard coagulation testing: activated partial thromboplastin time (aPTT), prothrombin time (PT), fibrinogen, D-dimers, platelets. An interest about viscoelastic coagulation testing methods is rising - use of rotational thromboelastometry (ROTEM) is mentioned in the newest European guidelines for hemostasis management. ROTEM has more advantages then standard tests. However, both tests have only grade 1C recommendation, and most of trials have been done on adults. The goal of the study is to compare a relationship between standard tests and ROTEM in pediatric patients in perioperative period to find out which test has better correlation with clinical status, to compare therapeutic strategies and time necessary for gain both of tests and to compare the difference in blood loss and blood products consumption in group treated by ROTEM versus standard tests. Reduced blood loss and amount of blood products transfusion is expected to be found in ROTEM group, representing lowering risk for the patient, all due to early evaluation of hemocoagulation and targeted therapy guided by ROTEM.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Usefulness of perioperative rotational thrombelastometry during scoliosis surgery in children.
Jonas J, Durila M, Malosek M, Maresova D, et al · · 2020 · cited 4× · PMID 31978886 · DOI 10.3171/2019.11.spine191137
Verify or expand the search:
- PubMed search for NCT03699813
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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 NCT03699813 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Motol
- Last refreshed: 11 October 2018
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/NCT03699813.
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