Comparison of Intralipid With SMOF Lipid Following HSCT

Recruiting now · Not applicable

Conditions studied: Leukemia, HSCT

In brief

The goal of this clinical trial is to have a successful engraftment in after bone transplantation. Acute leukemia patient of both sexes aged 2 to 18 years, who are transplant candidates, participate in this study. Primary hypothesis is Patients receiving SMOF LIPID will have better grafts than patients receiving intralipid. Also, complications after surgery and malnutrition will be less in this group.

Key facts

Study ID

NCT06625372

Run by

Shahid Beheshti University

People needed

50

Starts

2024-10-12

Expected to finish

2025-12-01

Last updated by the study team

2024-10-16

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willingness to cooperate and complete the informed consent form by the legal guardian of the child;
• Age ≤ 18 years;
• Definitive diagnosis of acute leukemia and candidate for hematopoietic stem ● cell transplantation;
• Eligible for parenteral nutrition support;
• No contraindications for parenteral nutrition;
• No history of allergy to egg or soy protein;
• Absence of severe organ failure or impaired liver function test (bilirubin \> 2.5 mg/dL).

You may not qualify if…

• Death of the child earlier than 5 days from the start of the intervention;
• Unwillingness to continue cooperation during study;
• Occurrence of side effects during the study;
• In case of sepsis, hypotension, shock, thrombosis, myocardial infarction, liver dysfunction, the patient will be excluded from the study.

Where it is running

• Children's Medical Center, Pediatrics Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran — Tehran, Iran (enrolling)

Full record on ClinicalTrials.gov

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