Status:
UNKNOWN
Role of Sirolimus in Treatment of Microcystic , Mixed Lymphatic and Vascular Malformations
Lead Sponsor:
Sohag University
Conditions:
Microcystic Lymphatic Malformation
Combined Vascular Malformation
Eligibility:
All Genders
6-12 years
Brief Summary
Lympho-vascular malformations result from errors in embryologic vasculogenesis involving capillaries, veins, arteries, lymphatics, or a combination of these. Infantile haemangiomas \& Vascular malform...
Detailed Description
Lympho-vascular malformations result from errors in embryologic vasculogenesis involving capillaries, veins, arteries, lymphatics, or a combination of these. Infantile haemangiomas \& Vascular malform...
Eligibility Criteria
Inclusion
- from age 6 months to 12 years , not before 6 months to complete their vaccination program \& maturation of hepatic enzymes .
- Patients diagnosed with microcystic \& mixed Lymphatic malformations .
- After failure of other lines of treatment as regard propranolol , steroid for infantile haemangiomas \& Vascular malformations and lymphovascular malformations .
- After failure of surgical excision \& injection of bleomycin of Lympho-vascular malformations
Exclusion
- Macrocystic Lymphatic malformations \& high flow vascular malformations like arterio-venous malformations .
- An active infection that requires systemic treatment during the attack .
- Side effects of the drug as ( history of an allergic reaction to sirolimus or patients who develop severe allergic reaction to drug during treatment , hyperlipidemia , leucopenia , etc… )
- Chronic liver or kidney disease or on chronic drug treatment as (steroids, interferon or chemotherapeutic agents) .
- An immunodeficiency condition such as a human immunodeficiency viral infection or primary immunodeficiency disease.
- Patients who received drug less than 6 months duration .
Key Trial Info
Start Date :
November 20 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06160739
Start Date
November 20 2023
End Date
September 1 2024
Last Update
December 15 2023
Active Locations (1)
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1
Sohag university Hospital
Sohag, Egypt