Effect of Fibrinogen infusion on bleeding amount during spine surgery
Phase 2
- Conditions
- Intraoperative massive bleeding.Hemorrhagic condition, unspecified
- Registration Number
- IRCT201307304969N8
- Lead Sponsor
- Iran University of Medical Sciences, Vice chancellor for research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 42
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method