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IRCT20180930041189N1 IRCT 2019-02-10 Shiraz University of Medical Sciences Serum fibrinogen and fibrin degradation products (FDP) changes in hypothermia and normothermia in patients undergoing bypass Assessing serum fibrinogen and fibrin degradation products (FDP) changes in hypothermia and normothermia in patients undergoing cardiopulmonary bypass 2018-05-22 anticipated 80 Complete https://irct.ir/trial/34156 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Comparison of fibrinogen in two groups of hypothermia and normothermia and, in particular, fibrinogen degradation products in these two conditions in patients under the bypass, Randomization description: Permutated blocks randomization size 4, Blinding description: Participants: After obtaining informed consent, they did not have information on which of the groups they were studying. Clinical caregivers: Clinical caregivers in the ICU did not have a patient group. Examiner Evaluation: The laboratory staff did not know which sample was for which group. Data analyzer: Descriptive data was coded and only researcher was aware of it. N/A coronary heart disease. Intervention 1: Intervention group: hyporthermic group: In this group, the temperature of the body was reduced untile 30- 34.9 ° C by a heater-cooler and a blanket (temperature changer). Intervention 2: Control group: normothermic group: Coronary artery disease is usually performed at 35- 36.5 ° C. Yes - There is a plan to make this available What will be shared: Initial measurements When: With the publication of the paper for a month To whom: Persons Investigating in Cardiac Surgery field Conditions: Use the data by naming the people of this study Where to obtain: To request data, contact m.ghodrati@gmail.com or call 09355975983. How to obtain: After receiving the email and accepting the above conditions to identify the researchers, the data will be delivered to the applicant within one day. Comments:
public Bahram Ghasemzadeh
Central Building, opposite the Palestine, Zend Street
shiraz Iran (Islamic Republic of) 71348-14336 +98 71 3230 5410 m.ghodrati87@gmail.com Shiraz University of Medical Sciences scientific Bahram Ghasemzadeh
Central Building, opposite the Palestine, Zend Street
shiraz Iran (Islamic Republic of) 71348-14336 +7 132305410 m.ghodrati87@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) All adult patients undergoing heart surgery Patients between 25 and 85 years 25 years 85 years Both History of thrombosis bleeding regular aspirin use in the past 5 days congenital fibrinogen disorders liver disease disorders or coagulation deficiencies genetic disorders such as hemophilia chronic renal failure patients people with substance abuse I25.1 Atherosclerotic heart disease of native coronary artery Treatment - Surgery Treatment - Surgery Intervention group: hyporthermic group: In this group, the temperature of the body was reduced untile 30- 34.9 ° C by a heater-cooler and a blanket (temperature changer). Control group: normothermic group: Coronary artery disease is usually performed at 35- 36.5 ° C. The amount of fibrinogen consumed and the production of fibrinogen degradation products. Timepoint: At the beginning of the study (before the intervention) and during the bypass in two intervals after the intervention. Method of measurement: Fibrinogen using the clauss and FDP method with serology (kit ELISA). Postoperative bleeding. Timepoint: 24 hours after entering ICU. Method of measurement: Measuring Chest tube bleeding. Shiraz University of Medical Sciences Approved 2018-07-29 Ethics committee of Shiraz University of Medical Sciences Zend Street, opposite the Palestine-Central Building shiraz Fars Iran (Islamic Republic of)