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IRCT20190209042660N1 IRCT 2020-06-15 Iran University of Medical Sciences comparing morbidity and mortality of Restrictive blood transfusion with a traditional approach in patients with a thermal burn A clinical trial on comparing morbidity and mortality of restrictive blood transfusion strategy with a traditional strategy in patients with a thermal burn 2018-09-22 anticipated 40 Complete https://irct.ir/trial/43402 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Other, Other design features: Following the meeting of the Research Council, the commencement of this research was reviewed by the Ethics Committee of Iran University of Medical Sciences and its implementation was morally permissible based on similar studies.Those who were included in the study were without any restriction on exclusion. The scholars of this project adhere to all Helsinki ethics. The routine burn management was done for all patients similarly. The hemoglobin level was frequently checked for early detection of any decline. Every patient who showed any sign of anemia received packed cell regardless of their order for threshold of transmission. After a blood transfusion, the patient's clinical symptoms and possible side effects will be assessed. All patients were given blood transfusions as much as required, during surgical procedures if they were hemodynamically unstable or had lost a large volume of blood, regardless of their protocol. After discharge, the researchers extracted and recorded all the data and information needed from the patient's file and hospital management system.Four categories of information were recorded for each patient as follows:• At the time of admission: Demographic information including sex and age, smoking habits, depth and percentage of burns based on TBSA, co-incidence of inhalation burns, other factors that may affect blood transfusions, including heart disease, performing escharotomy on arrival. • During admission: number and type of surgical procedure (including debridement, graft, early excision, escharotomy, amputation, surgery for associated trauma, etc.), length of stay in ICU, and coagulation disorder• Information about blood transfusion: Hemoglobin levels before the first blood transfusion, total number of blood units received, number of units received per injection time (before the first surgery, during surgery and out of the operating room after surgery), length of hospital stays until the first injection• Events occurred during the admission: Mortality during hospitalization for any cause, occurrence of complications (including wound infection, positive blood culture, sepsis, cardiac or pulmonary problems, neurologic defects and compartment syndrome), total number of episodes of infection (any kind of infection), duration of hospitalization, blood culture, Randomization description: Using the simple randomization method, all eligible patients were assigned to the intervention and control groups one by one before each procedure, Blinding description: In this double-blind study, each individual was randomly assigned to one of two intervention and control groups, with only one physician authoring the admission order for blood transfusion and the executing nurse being aware of the group to which the individual belongs. Each person is assigned a numeric code and the data is entered into the software by the lead researcher who has no knowledge of the strategy being executed against each code. The analyzer is aware of the strategy implemented for each individual and reports the statistical results of the two groups analysis. 3 Condition 1: anemia. Condition 2: thermal burn. Condition 3: blood transfusion side effects. Intervention 1: Intervention group: blood transfusion when hemoglobin level is below 8 g/dl. Intervention 2: Control group: blood transfusion when hemoglobin level is below 10 g/dl. Yes - There is a plan to make this available What will be shared: Result of data analysis When: Start of access period from 2020 To whom: General practitioners and specialists Conditions: If they are studying similar field or consulting on a treatment decision Where to obtain: Email Mr. Maziar Daniali to mazidani87@gmail.com How to obtain: Within 2 weeks of receiving the email request for data access Comments:
public Maziar daniali
Rasool-e-Akram hospital, Maziar Mansoori St, Sattarkhan St
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 8811 mazidani87@gmail.com Iran University of Medical Sciences scientific Hamid Salehi
Motahhari hospital, Rashid Yasemi St, Vanak,Tehran, Tehran province, Iran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8877 0031 salehi.ha@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Total Body Surface Area more than 20 percent Admission to the burn center where the study took place in first 96 hours after the injury 18 years no limit Both a known history of allergic reactions secondary to blood transfusions pregnancy history of requiring hemodialysis Brain death Angina or acute myocardial infarction known history of hematologic disorder blood transfusion at another center prior to admission those who were unlikely to survive, according to the experienced burn specialists impaired coagulation D62 T31 Y64.0 Acute posthemorrhagic anemia Burns classified according to extent of body surface involved Contaminated medical or biological substance, transfused or infused N/A N/A Intervention group: blood transfusion when hemoglobin level is below 8 g/dl Control group: blood transfusion when hemoglobin level is below 10 g/dl Total unit of transfused blood. Timepoint: Discharge date. Method of measurement: Patient file. Total number of reported infection. Timepoint: Discharge date. Method of measurement: patient file. Hospitalization time. Timepoint: discharge date. Method of measurement: patient file. Mortality rate during admission. Timepoint: discharge date. Method of measurement: patient file. Iran University of Medical Sciences Approved 2019-02-10 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, next to Milad tower, Hemmat highway Tehran Tehran Iran (Islamic Republic of)