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IRCT201012264784N2 IRCT 2012-06-11 Tehran University of Medical Siences- Vice-chancellor for reseach Effect of prophylactic administration of fibrinogen concentrate on volume of transfused packed RBC during and after totla hip arthroplasty. Effect of prophylactic administration of fibrinogen concentrate on volume of transfused packed RBC during and after totla hip arthroplasty in sina hospital during 2011-2012. 2011-04-21 anticipated 30 Complete https://irct.ir/trial/5126 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. N/A totla hip arthroplasy. Intervention 1: In case group after induction of anesthesia we infuse 30mg/kg fibrinogen concentrtate IV in 15 minutes.before infusion by means of arterial catheter blood sampling perform and check it for serum level of fibrinogen in both groups( for baseline).during surgery with 30 minute intervals mean atreial pressure would be registered.blood loss is estimated by means of caclculating number of guazes an longuazes and suction container.each guaze and longuaze consist of 20 and 50 ml respectively.maximum allowable blood loss would be calculated by this equationABL=65 X body weightX(patient Hb - desired Hb for sex an age)/optimal Hb.volume of packed RBC contains about 250 ml RBC which would be diluted with 250 ml warm normal saline and transfused for compensation of blood loss.during surgery with warm crystaloids and warm forced air and thermal monitoring maintaining normothermia.monitoring of acid base would be performed. Intervention 2: In control(placebo) group after induction of anesthesia we infuse normal saline in equivalent volume of fibrinogen.before infusion by means of arterial catheter blood sampling perform and check it for serum level of fibrinogen in both groups( for baseline).during surgery with 30 minute intervals mean atreial pressure would be registered.blood loss is estimated by means of caclculating number of guazes an longuazes and suction container.each guaze and longuaze consist of 20 and 50 ml respectively.maximum allowable blood loss would be calculated by this equationABL=65 X body weightX(patient Hb - desired Hb for sex an age)/optimal Hb.volume of packed RBC contains about 250 ml RBC which would be diluted with 250 ml warm normal saline and transfused for compensation of blood loss.during surgery with warm crystaloids and warm forced air and thermal monitoring maintaining normothermia.monitoring of acid base would be performed.
public Dr.Reza shariat Moharari
emam khomeini street-sina hospital
tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 moharari@sina.tums.ac.ir sina hospital-tehran university of medical sciences scientific Dr.Atabak Nadjafi
emam khomeini street- sina hospital
tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 nadjafia@tums.ac.ir associated professor-department of anesthesia and critical care-sina hospital TUMS Iran (Islamic Republic of) Inclusion criteria: 1- patients aged 35-75 years old scheduled for total hip arthroplasty 2-ASA physical status I and II 3-hemoglubin level more than 10 4-MET more than 4 5-completely fill and sign the informed consent. Exclusion criteria: 1-ASA class more than 3 2-MET<4 3-pregnancy 4-history of allergic reaction to blood products specially fibrinogen concentrate 5-history of DVT and pulmunary emboli and any embolic events. 6-recent MI and CVA during last 6 month 7-known cases of coagulopathy and thrombocytopenia. 35 years 75 years Both Z96.6 Hip-joint replacement (partial)(total) Prevention Prevention In case group after induction of anesthesia we infuse 30mg/kg fibrinogen concentrtate IV in 15 minutes.before infusion by means of arterial catheter blood sampling perform and check it for serum level of fibrinogen in both groups( for baseline).during surgery with 30 minute intervals mean atreial pressure would be registered.blood loss is estimated by means of caclculating number of guazes an longuazes and suction container.each guaze and longuaze consist of 20 and 50 ml respectively.maximum allowable blood loss would be calculated by this equationABL=65 X body weightX(patient Hb - desired Hb for sex an age)/optimal Hb.volume of packed RBC contains about 250 ml RBC which would be diluted with 250 ml warm normal saline and transfused for compensation of blood loss.during surgery with warm crystaloids and warm forced air and thermal monitoring maintaining normothermia.monitoring of acid base would be performed. In control(placebo) group after induction of anesthesia we infuse normal saline in equivalent volume of fibrinogen.before infusion by means of arterial catheter blood sampling perform and check it for serum level of fibrinogen in both groups( for baseline).during surgery with 30 minute intervals mean atreial pressure would be registered.blood loss is estimated by means of caclculating number of guazes an longuazes and suction container.each guaze and longuaze consist of 20 and 50 ml respectively.maximum allowable blood loss would be calculated by this equationABL=65 X body weightX(patient Hb - desired Hb for sex an age)/optimal Hb.volume of packed RBC contains about 250 ml RBC which would be diluted with 250 ml warm normal saline and transfused for compensation of blood loss.during surgery with warm crystaloids and warm forced air and thermal monitoring maintaining normothermia.monitoring of acid base would be performed. Volume of transfused packed RBC during and after totla hip arthroplasty surgery. Timepoint: any time during and after surgery that needs transfusion. Method of measurement: in mili liter. Volume of bleeding during and after totla hip arthroplasty surgery. Timepoint: during and after surgery. Method of measurement: calculating number of gauzes and longauze and suction fluid in mililiter. Level of hemoglobin during and after surgery. Timepoint: during and 24 hour after surgery. Method of measurement: check of hemoglobin level in perioperative period by CBC test. Complications of transfusion. Timepoint: during and after surgery. Method of measurement: subjective if the patient is awakw and objective if the patient is anesthesized. Volume of transfused other blood products. Timepoint: during and after surgery. Method of measurement: as mililiter or unit of transfused product. Thromboembolic events. Timepoint: during hospitalisation and after discharge up to 2 weeks(according to fibrinogen half life). Method of measurement: by post operative visit and examination, phone follow up until 2 weeks after discharge. Transfusion related long term complication. Timepoint: long term after surgery. Method of measurement: subjective by patient declarement or complain or objective by take history and physical exam and labratory tests if needed. Cardiovascular complications due to bleeding. Timepoint: during and after surgery. Method of measurement: ECG monitoring and 12 lead ECG trace record during aneshtesia ,history and physical exam after surgery. Tehran University of Medical Siences- Vice-chancellor for reseach Approved 2011-07-28 committee of ethics in research-Tehran University of Medical Sciences keshavarz Blv- edge of qods St-6 th floor -central organisation of TUMS tehran Iran (Islamic Republic of) Approved 2011-07-28 TUMS committe of ethics in research keshavarz Blv- edge of qods St-central organisation of TUMS tehran Iran (Islamic Republic of)