]>
IRCT201307304969N8 IRCT 2015-04-22 Iran University of Medical Sciences, Vice chancellor for research Effect of Fibrinogen infusion on bleeding amount during spine surgery Comparison of the effect of prophylactic fibrinogen and placebo infusion on perioperative bleeding in posterior spinal fusion surgery, a randomized clinical trial 2012-09-22 anticipated 42 Complete https://irct.ir/trial/5330 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. 2-3 Intraoperative massive bleeding. Intervention 1: Infusion of 1 g fibrinogen powder(CSL Behring,USA) in 20 milliliter saline normal intravenously before anesthesia in case group. Intervention 2: Infusion of 20 milliliter saline normal before anesthesia in control group.
public Alireza Pournajafian
Beh Afarin st.- Karim khan Ave.
Tehran Iran (Islamic Republic of) +98 21 8894 6762 alipn78@yahoo.com Firoozgar Hospital scientific Alireza Pournajafian
Beh Afarin St.- Karim khan Ave.
Tehran Iran (Islamic Republic of) +98 21 8894 6762 alipn78@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Patients candidate for elective posterior spine fusion surgery, preoperative serum fibrinogen level between 2-4 g/l, ASA I,II , age 18-60y, BMI less than 30 kg/m2, duration of surgery between 1-4 h, Exclusion criteria: history of previous PSF, pulmonary, cardiac, hepatic, renal or coagulation disorders, hypertension, using beta blocker, calcium blocker, digoxine, TCAs, anticoagulant and clonidin by patient, alcohol or drug abuse, existing tumor in the site of surgery, surgery in more than 3 levels 18 years 60 years Both D69.9 Hemorrhagic condition, unspecified Prevention Placebo Infusion of 1 g fibrinogen powder(CSL Behring,USA) in 20 milliliter saline normal intravenously before anesthesia in case group Infusion of 20 milliliter saline normal before anesthesia in control group Amount of bleeding. Timepoint: during surgery and in recovery room. Method of measurement: Watching scaled bottle of suction in milliliter. Number of infused Blood bags. Timepoint: At the end of surgery. Method of measurement: Counting the number of infused blood bags. Serum fibrinogen. Timepoint: just before and the day after surgery. Method of measurement: Special laboratory kit for measuring fibrinogen. Hemoglobin. Timepoint: The day before and 4 hours after surgery. Method of measurement: Measurement of hemoglobin by laboratory. Iran University of Medical Sciences, Vice chancellor for research Approved 2014-12-03 Ethics committee of Iran University of Medical Sciences Next to Milad Tower- Hemmat Highway Tehran Iran (Islamic Republic of)