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NCT03634215
Estimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in Trauma
trial testing fibrinogen plasma concentration, coagulation factor XIII activity in Multiple Trauma in 357 participants. Completed in 31 March 2019.
31 January 2019
Quick facts
| Lead sponsor | Masaryk Hospital Krajská zdravotní a.s. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 357 |
| Start date | 1 September 2018 |
| Primary completion | 31 January 2019 |
| Estimated completion | 31 March 2019 |
| Sites | 3 locations across Czechia |
Drugs / interventions tested
- fibrinogen plasma concentration, coagulation factor XIII activity
Conditions studied
- Multiple Trauma — all drugs for Multiple Trauma →
- Coagulation Disorder — all drugs for Coagulation Disorder →
- Coagulation Factor Deficiency — all drugs for Coagulation Factor Deficiency →
- Coagulation Defect; Acquired — all drugs for Coagulation Defect; Acquired →
Sponsor
Masaryk Hospital Krajská zdravotní a.s.
Who can join
18 and older, any sex, with Multiple Trauma or Coagulation Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Coagulation factor XIII (FXIII), a plasma transglutaminase, is known as the final enzyme of the coagulation cascade, responsible for a cross-linking of fibrin to strengthen blood clot. It also minimizes fibrin degradation by its cross-linking it with alfa2-antiplasmin molecules. It has been found that similar to plasma fibrinogen level, FXIII activity can be reduced in the early phase of severe trauma. Therefore, its immediate substitution is of potential therapeutic interest in trauma-induced coagulopathy. However, unlike plasma fibrinogen level evaluation, measurement of the FXIII activity is not routinely available. Therefore, targeted substitution of FXIII is practically impossible. The plasma fibrinogen level is routinely measured in severe trauma patients. Based on pathophysiologic assumptions and a limited number of published data we hypothesize that the FXIII activity correlates with fibrinogen level. In such case, indirect FXIII activity prediction by fibrinogen level measurement would be a convenient approach to enable FXIII targeted substitution. Therefore we decided to perform a prospective observational clinical trial to determine whether the low plasma fibrinogen level in severe trauma correlates with decreased FXIII activity.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Recent advances in use of fresh frozen plasma, cryoprecipitate, immunoglobulins, and clotting factors for transfusion support in patients with hematologic disease.
Nair PM, Rendo MJ, Reddoch-Cardenas KM, Burris JK, et al · · 2020 · cited 19× · PMID 32892846 · DOI 10.1053/j.seminhematol.2020.07.006
Verify or expand the search:
- PubMed search for NCT03634215
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Trials by the same sponsor.
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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 NCT03634215 (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 Masaryk Hospital Krajská zdravotní a.s.
- Last refreshed: 4 January 2023
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/NCT03634215.
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