Safety and preliminary efficacy of Alkaline Phosphatase in severely burned patients

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29043

Enrollment

Registered

2020-06-16

Start date

2021-09-21

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Patients with acute thermal burns of at least 15% TBSA Severe burns

Interventions

"Alkaline phosphatase is an enzyme which is involved in normal physiology. The medicinal product consists of alkaline phosphatase (bRESCAP

purified from bovine intestines) in a glycerol containing liquid which will be reconstituted in normal saline"

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: • Inclusion in another interventional clinical trial • Age < 18 • Age > 80 • Patients who are pregnant or lactating • Patients expected to have fatal disease within 24 hours • Patients who have advanced chronic liver disease confirmed by a Child-Pugh C • 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 with active haematological malignancy

Design outcomes

Primary

Measure	Time frame
The safety as in number of (serious) adverse events within 30 days after initiation of AP treatment is the primary endpoint. According to Dutch regulations (CCMO) all AE’s and SAE’s will be monitored and reported. To monitor the complications all possible adverse events, expected and unexpected ones, are recorded and noted in the CRF. Adverse events are defined as any unusual experience occurring to a subject during the study, whether or not considered related to alkaline phosphatase. This includes fever without suspicion, skin rash and signs of an allergic reaction (as suspected by the physician) will be reported.	—

Measure

Time frame

The safety as in number of (serious) adverse events within 30 days after initiation of AP treatment is the primary endpoint. According to Dutch regulations (CCMO) all AE’s and SAE’s will be monitored and reported. To monitor the complications all possible adverse events, expected and unexpected ones, are recorded and noted in the CRF. Adverse events are defined as any unusual experience occurring to a subject during the study, whether or not considered related to alkaline phosphatase. This includes fever without suspicion, skin rash and signs of an allergic reaction (as suspected by the physician) will be reported.

—

Secondary

Measure	Time frame
Length of stay ICU/ hospital, time to reach complete (>95%) wound closure, number of surgical procedures, mortality at 30 days. Also, values of inflammatory markers (e.g. macrophages, neutrophils, lymphocytes and their inflammatory products (TNF-a, IL-1ß, IL-6, IL-8, IL-10, and IL-18) over time will be analysed.	—

Contacts

Public ContactEvelien de Jong

Rode Kruis Ziekenhuis Beverwijk

edejong@rkz.nl0251783807

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)