An interventional study of SMOF lipid and INTRALIPIDS in Leukemia and HSCT, sponsored by Shahid Beheshti University. Recruiting at 1 site in Iran, Islamic Republic of. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by Shahid Beheshti University · Not applicable, Interventional, and Supportive care
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.
Patients will be randomly divided into two groups: the intervention group (TPN based on SMOFLipid) and the control group (TPN based on IntraLipid). At baseline (before HSCT) and after obtaining informed consent and assent, blood samples will be collected to test for biochemical markers, including total cholesterol, TG, LDL, HDL, FBS, Alb, Na, K, Ph, Ca, Mg, CRP, IL-6, BUN, Cr, and CBC. Furthermore, data on nutritional intake (total energy and protein) and appetite status will be gathered. The primary outcomes are neutrophil and platelet engraftment, defined as \>500 for neutrophils and \>20,000 for platelets, respectively. The possibility of oral intake, as well as the achievement of oral + ONS and total oral nutrition alongside TPN duration, will be recorded. On days +15 and +30, biochemical and anthropometric markers will be collected again. Furthermore, clinical outcomes such as acute GVHD, cholestasis, bleeding, infections, hospitalization, and mortality will be reported.
2,381 studies on the registry are indexed under Leukemia; 253 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 1,769 interventional studies indexed under Leukemia.
Browse Leukemia studies →Shahid Beheshti University is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The SMOF lipid is given to the patient as a fat component of total parenteral nutrition.
Dietary Supplement: SMOF lipid
intralipids
Dietary Supplement: INTRALIPIDS
The SMOF lipid is given to the patient as a fat component of total parenteral nutrition.
The Intralipid will be given to the patient as fat component of total parenteral nutrition.
Engraftment
blood counts of Neutrophils and platelets
Time frame: Within 35 days after transplantation
100-day survival rate
Determination and comparison of 100-day survival rate after transplantation in both groups
Time frame: Within 100 days after transplantation
Incidence of infection
Determining and comparing the incidence of infection
Time frame: Within 30 days after transplant
Incidence of bleeding
Determining and comparing the incidence of bleeding
Time frame: Within 30 days after transplantation
Hospitalization
Determining and comparing the duration of hospitalization in both groups
Time frame: up to 7 weeks after transplantation
Mortality
incidence of mortality in hospital
Time frame: up to 7 weeks after transplantation
MAC (mid arm circumference)
Determination and comparison of MAC in both groups
Time frame: On days 15 and 30 after transplantation
Albumin
Determination and comparison of serum albumin
Time frame: On days 15 and 30 after transplantation
Acute gastrointestinal complications
Determining and comparing the incidence of acute gastrointestinal complications (including acute GVHD, cholestasis) in both groups.
Time frame: Up to 100 days after transplantation
Duration of parenteral nutrition
Determining and comparing the duration of using parenteral nutrition
Time frame: during hospitalization, up to 7 weeks after transplantation
Weight
Determination and comparison of weight in both groups
Time frame: On days 15 and 30 after transplantation
Blood sugar
Determination and comparison of blood sugar,
Time frame: On days 15 and 30 after transplantation
Serum electrolytes
Determination and comparison of serum electrolytes
Time frame: On days 15 and 30 after transplantation
Serum lipids
Determination and comparison of serum lipids
Time frame: On days 15 and 30 after transplantation
Serum Interleukin 6 (IL-6)
Determination of serum interleukin 6 (IL-6)
Time frame: On days 15 and 30 after transplantation
Plan to share: No
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Studies of the drug tested here: SMOFlipid
Shahid Beheshti University