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

Recruiting

• Conditions: D68.4; Acquired coagulation factor deficiency

• Registration Number: DRKS00030706
• Lead Sponsor: CSL Behring GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

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

Hereditary FXIII-Deficiency

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The endpoint for the primary objective is the initial level of FXIII activity in patients with supplementation.

Secondary Outcome Measures

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