Clinical trial · Interventional
Comparison of Intralipid With SMOF Lipid Following HSCT
Comparison of the Effect of Intralipid Parenteral Nutritional With SMOF Lipid Parenteral Nutritional on Biochemical Markers, Hematologic Markers, and Clinical Outcomes Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HSCT | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INTRALIPIDS | Dietary Supplement | — | UNRESOLVED |
| SMOF lipid | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SMOF lipid
- description
- The SMOF lipid is given to the patient as a fat component of total parenteral nutrition.
- interventionNames
- Dietary Supplement: SMOF lipid
- type
- ACTIVE_COMPARATOR
- label
- Intralipid
- description
- intralipids
- interventionNames
- Dietary Supplement: INTRALIPIDS
Primary outcomes (1)
- measure
- Engraftment
- timeFrame
- Within 35 days after transplantation
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available