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IRCT20130304012695N16 IRCT 2023-04-17 Deputy of Research,Tehran University of Medical Sciences Heparin thrapy in brain dead patients Measurement of blood levels of D-dimer and CRP in brain dead patients and the effect of heparin with therapeutic dose on early renal and hepatic function of these organs in brain dead patients 2021-04-09 anticipated 73 Complete https://irct.ir/trial/69401 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For the randomization of patients who meet the inclusion criteria, the method of four blocks including intervention and control groups will be used.The preparation of randomization sequences will be done using the Random Generator software and the created sequences will be given to a trained staff member of the intensive care of unit who is not a member of the research group.The researchers of this study will not be aware of the existing sequences and arrangement of the blocks.After the patient enters the operating room, the trained person removes the first sequence from the special box of this study and according to the predetermined protocol, if it is H, it will be transferred to the intervention group, and if it is C, it will be transferred to the control group, Blinding description: In this study, patients do not know their group. Eligible participants to receive heparin therapy (group H) or prophylactic heparin (group C) are determined according to a computerized randomization program.These drugs are prepared in syringes and the same volume and are identified with the patient's name and hospital registration number, and in the special care department, these drugs are given to the nurse caring for the patient who is blind to the assigned groups for injection.Another investigator, who is blinded to the assigned groups, will evaluate the status of transplant success in kidney and liver recipients. 1-2 Condition 1: Brain dead. Condition 2: Thrombophilia. Intervention 1: Intervention group: After the confirmation of brain death of the patients and their family's consent to organ donation, first blood samples were measured to check CRP and D-dimer and 5000 units of heparin (manufactured by Caspian Tamin Company) with the help of the special care nurse according to the patient grouping. prepared and injected intravenously every 6 hours until the moment of organ donation and routine care to maintain the patient's hemodynamics continues until the moment of organ donation. Intervention 2: Control group: After the confirmation of brain death of the patients and their family's consent to organ donation, first blood samples were measured to check CRP and D-dimer and 5000 units of heparin (manufactured by Caspian Tamin Company) with the help of the special care nurse according to the patient grouping. prepared and injected intravenously every 12 hours until the moment of organ donation and routine care to maintain the patient's hemodynamics continues until the moment of organ donation. Yes - There is a plan to make this available What will be shared: Main study outcome data When: Six months after the end of the study To whom: University researchers Conditions: Share experiences to increase the knowledge Where to obtain: khajavim@tums.ac.ir -Dr.khajavi How to obtain: The request will be made by email and the answer will be given within two months Comments:
public Mohammad Reza Khajavi
Sina Hospital,Hasan Abad Sq, Imam Khomeni St
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 0000 KHAGAVIM@TUMS.AC.IR Tehran University of Medical Sciences scientific Mohammad Reza Khajavi
Sina Hospital,Hasan Abad Sq,Imam Khomeni St
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 0000 KHAGAVIM@TUMS.AC.IR Tehran University of Medical Sciences Iran (Islamic Republic of) Brain death patients in the ages of 10 to 60 years Renal failure patients undergoing dialysis on the transplant list Liver failure patients on the transplant list Brain death patients with D-dimer more than 500ng/ml Brain death patients with CRP greater than 20mg/L 10 years 60 years Both Brain death patients who have Cr≥2.5 mg/dl. Renal failure patients who did not have a history of previous successful transplantation Liver failure patients who did not have a history of previous successful transplantation G96.8 D68.69 Other specified disorders of central nervous system Other thrombophilia Treatment - Drugs Treatment - Drugs Intervention group: After the confirmation of brain death of the patients and their family's consent to organ donation, first blood samples were measured to check CRP and D-dimer and 5000 units of heparin (manufactured by Caspian Tamin Company) with the help of the special care nurse according to the patient grouping. prepared and injected intravenously every 6 hours until the moment of organ donation and routine care to maintain the patient's hemodynamics continues until the moment of organ donation Control group: After the confirmation of brain death of the patients and their family's consent to organ donation, first blood samples were measured to check CRP and D-dimer and 5000 units of heparin (manufactured by Caspian Tamin Company) with the help of the special care nurse according to the patient grouping. prepared and injected intravenously every 12 hours until the moment of organ donation and routine care to maintain the patient's hemodynamics continues until the moment of organ donation Serum urea and creatinine of kidney transplant recipients. Timepoint: At the beginning of the patient's entry into the study and then daily until 7 days after transplantation. Method of measurement: By sending patients' blood samples to the laboratory. Measurement of liver enzymes and bilirubin in liver transplant recipients. Timepoint: At the beginning of the patient's entry into the study and then daily until 7 days after transplantation. Method of measurement: By sending patients' blood samples to the laboratory. Measurement of D-dimer in brain death patients. Timepoint: Once and 24 hours before organ donation. Method of measurement: By sending patients' blood samples to the laboratory. Measurement of CRP in the blood of brain dead patients. Timepoint: Once and 24 hours before organ donation. Method of measurement: By sending patients' blood samples to the laboratory. Deputy of Research,Tehran University of Medical Sciences Approved 2020-11-01 Research Ethics Committees of Sina Hospita Sina Hospital, Imam Khomeini st. Tehran Tehran Iran (Islamic Republic of)