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Acquired FXIII Deficiency: Real World Evidence on Laboratory Diagnosis and presentation of FXIII supplementation

Acquired FXIII Deficiency: Real World Evidence on Laboratory Diagnosis and presentation of FXIII supplementation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00030706
Enrollment
200
Registered
2022-12-20
Start date
2023-06-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

D68.4

Interventions

Group 1: Patients with FXIII activity measurements. Retrospective evaluation of parameters recorded in routine clinical practice, especially postoperative bleeding and wound healing disorders. Group 2

Sponsors

CSL Behring GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Full age Part A: Inpatients who underwent FXIII measurement, consecutive within a 3-4 month period if possible. Part B: Inpatients who were treated with FXIII supplementation by March 31, 2022.

Exclusion criteria

Exclusion criteria: Hereditary FXIII-Deficiency

Design outcomes

Primary

MeasureTime frame
The endpoint for the primary objective is the initial level of FXIII activity in patients with supplementation.

Secondary

MeasureTime frame
Endpoints for secondary objectives are triggers for FXIII determinations and possible causes for clinically relevant FXIII deficiency. FXIII treatment outcomes are determined by the specific wound size, hemostasis, and Physician assessment of treatment outcome. In addition, FXIII treatment modalities are recorded with the dose administered and frequency of dosing.

Countries

Germany

Contacts

Public ContactFelix Schmitt

Universitätsklinikum Heidelberg Klinik für Anästhesiologie

Felix.Schmitt@med.uni-heidelberg.de062215639421

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026