Skip to content

Comparison of effectiveness of Different doses of prophylactic intravenous fibrinogen versus normal saline on intraoperative bleeding in posterior spinal fusion surgery

Comparison of effectiveness of Different doses of prophylactic intravenous fibrinogen versus normal saline on intraoperative bleeding in posterior spinal fusion surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210415050983N3
Enrollment
40
Registered
2023-02-17
Start date
2023-05-05
Completion date
Unknown
Last updated
2023-03-13

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

Conditions

Lumbar Discopathy. Intervertebral disc disorders with myelopathy, thoracolumbar region

Interventions

Intervention 1: Intervention group: They are divided into two groups receiving one gram of fibrinogen (F1) and two grams of fibrinogen (F2). Ten minutes after the operation, the first group received 1
CSL Behring, Pennsylvania) intravenously. which is dissolved in 50 ml of distilled water, as described by the manufacturer, the second group receives 2 grams of fibrinogen. Intervention 2: Control gro

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: No history of drug allergy No history of thromboembolism and coagulation disorders No history of liver or kidney failure No history of heart disease and hypertension ASA I , II Patient consent to participate in the study

Exclusion criteria

Exclusion criteria: use of anticoagulants History of blood disorders and coagulopathy History of liver disease History of chronic kidney disease and creatinine greater than 2mg / dl History of thromboembolic events at any time

Design outcomes

Primary

MeasureTime frame
Determination of intraoperative bleeding in groups receiving fibrinogen and control group. Timepoint: End of surgery. Method of measurement: Bleeding volume during field operation, blood gases, suction.;Determining the duration of surgery in the groups receiving fibrinogen and the control group. Timepoint: End of surgery. Method of measurement: hours / minutes.;Amount of blood and blood products injected. Timepoint: End of surgery. Method of measurement: The number of units to be injected.;Comparison of different doses of prophylactic fibrinogen on the above outcomes. Timepoint: End of surgery. Method of measurement: Fibrinogen one gram and two grams.

Secondary

MeasureTime frame
Determining the duration of surgery in the groups receiving fibrinogen and the control group. Timepoint: End of surgery. Method of measurement: hours / minutes.;Determination of recovery time after reverse dose injection in groups receiving fibrinogen and control group. Timepoint: End of surgery. Method of measurement: hours / minutes.;Determining the length of stay in the intensive care unit in the groups receiving fibrinogen and the control group. Timepoint: End of surgery. Method of measurement: hours / minutes.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSogol Asgari

Shahid Beheshti University of Medical Sciences

Drasgari98429@gmail.com+98 21 5541 9005

Outcome results

None listed

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