Skip to content

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201307304969N8
Enrollment
42
Registered
2015-04-22
Start date
2012-09-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative massive bleeding. Hemorrhagic condition, unspecified

Interventions

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
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

Sponsors

Iran University of Medical Sciences, Vice chancellor for research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Pournajafian

Firoozgar Hospital

alipn78@yahoo.com+98 21 8894 6762

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026