Children's Medical Center, Pediatrics Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran
Tehran, Iran
Location status: Recruiting
Location contact
Amirali hamidieh
CONTACT
NCT Number: NCT06625372
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.
Interested in participating?
Request Info2 year–18 year
All sexes
Interventional
Not applicable
Tehran, Iran
Location status: Recruiting
Amirali hamidieh
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Within 35 days after transplantation
blood counts of Neutrophils and platelets
Time frame: Within 100 days after transplantation
Determination and comparison of 100-day survival rate after transplantation in both groups
Time frame: Within 30 days after transplant
Determining and comparing the incidence of infection
Time frame: Within 30 days after transplantation
Determining and comparing the incidence of bleeding
Time frame: up to 7 weeks after transplantation
Determining and comparing the duration of hospitalization in both groups
Time frame: up to 7 weeks after transplantation
incidence of mortality in hospital
Time frame: On days 15 and 30 after transplantation
Determination and comparison of MAC in both groups
Time frame: On days 15 and 30 after transplantation
Determination and comparison of serum albumin
Time frame: Up to 100 days after transplantation
Determining and comparing the incidence of acute gastrointestinal complications (including acute GVHD, cholestasis) in both groups.
Time frame: during hospitalization, up to 7 weeks after transplantation
Determining and comparing the duration of using parenteral nutrition
Time frame: On days 15 and 30 after transplantation
Determination and comparison of weight in both groups
Time frame: On days 15 and 30 after transplantation
Determination and comparison of blood sugar,
Time frame: On days 15 and 30 after transplantation
Determination and comparison of serum electrolytes
Time frame: On days 15 and 30 after transplantation
Determination and comparison of serum lipids
Time frame: On days 15 and 30 after transplantation
Determination of serum interleukin 6 (IL-6)
Contact information is provided by the study sponsor or research team.
Zahra Vahdat Shariatpanahi, Professor
CONTACT
Zahra Vahdat Shariatpanahi, Professor
CONTACT
Shahid Beheshti University
Other
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)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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