Effect of Fresh Frozen Plasma on Bleeding in Spine Surgery

Effects of preoperative fresh frozen plasma administration on reducing bleeding in patients undergoing posterior spinal fusion surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200502047277N14

Enrollment

100

Registered

2025-02-05

Start date

2025-02-08

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Bleeding during surgery, also known as intraoperative bleeding, refers to blood loss that occurs while a surgical procedure is being performed. In posterior spinal fusion (PSF) surgery, excessive bleeding is a common challenge due to the extensive vascular supply in the spinal region. Uncontrolled intraoperative bleeding can increase the risk of surgical complications, prolong the operation time, and necessitate blood transfusions, which carry their own risks.. Haemorrhage and haematoma complic

Interventions

Intervention 1: Intervention group: the intervention group consists of patients receiving one bag of fresh frozen plasma (FFP) intravenously, administered 30 minutes before surgery. This intervention

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Adults aged 18–70 years Scheduled for elective posterior spinal fusion (PSF) surgery. Hemoglobin level >10 g/dL preoperatively. Normal coagulation profile (e.g., PT, INR, aPTT within standard reference ranges). No prior history of blood disorders or coagulopathies. Ability to provide written informed consent. Weight between 65–80 kg.

Exclusion criteria

Exclusion criteria: Known congenital or acquired coagulopathy. Active liver disease or history of hepatic failure. Recent use of anticoagulants (e.g., warfarin, heparin) within the last 14 days. Allergy to or contraindications for fresh frozen plasma (FFP). Pregnancy or breastfeeding. Scheduled for emergency spine surgery.

Design outcomes

Primary

Measure	Time frame
The primary outcome is the total intraoperative blood loss measured in milliliters (mL). This outcome will assess the effectiveness of preoperative fresh frozen plasma (FFP) administration in reducing surgical blood loss during posterior spinal fusion (PSF) surgery. Timepoint: Blood loss will be measured intraoperatively during surgery. Method of measurement: The total volume of blood loss will be measured using a surgical suction device, gauze weighing method, and estimated blood loss based on visual inspection by the surgical team.	—

Measure

Time frame

The primary outcome is the total intraoperative blood loss measured in milliliters (mL). This outcome will assess the effectiveness of preoperative fresh frozen plasma (FFP) administration in reducing surgical blood loss during posterior spinal fusion (PSF) surgery. Timepoint: Blood loss will be measured intraoperatively during surgery. Method of measurement: The total volume of blood loss will be measured using a surgical suction device, gauze weighing method, and estimated blood loss based on visual inspection by the surgical team.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeed Oraee Yazdani

Shahid Beheshti University of Medical Sciences

Saeed_o_yazdani@yahoo.com+98 21 25719

Outcome results

None listed

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