Safety and preliminary efficacy of Alkaline Phosphatase in severely burned patients

Phase 1

• Conditions: Severe Burns; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2019-004826-12-NL
• Lead Sponsor: Association of Dutch Burn Centres

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-22
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

•partial/full thickness acute thermal burns of at least 15% TBSA
•Admission burn ICU
•Age =18
•Written informed consent from patient or legal representative

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

•Inclusion in another interventional clinical trial
•Patients who are pregnant or lactating
•Patients expected to have fatal disease within 24 hours
•Patients with chemical burns
•Patients who are having an known history of immune system that has been impaired by disease, such as patients with HIV and with a CD4 count of less than 200 cells/mm, neutropenic patients (<0.5 x 109/l) or medical treatment with immunosuppressive effects
•Patients who have advanced chronic liver disease confirmed by a Child-Pugh C
•Patients with active haematological malignancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified