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Prophylactic fibrinogen infusion to reduce blood loss in multilevel lumbar spinal fusion.

Prophylactic Fibrinogen Infusion in Multilevel Spinal Fusion (PFI/MSF): A Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202609861307035
Enrollment
52
Registered
2026-09-04
Start date
2023-01-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Musculoskeletal Diseases

Interventions

Control

Sponsors

Departement of anesthesiology Sahloul hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Age = 18 years • Scheduled for multilevel lumbar spinal fusion (= 2 levels) with decompression • ASA physical status I–II • Hemoglobin = 12 g/dL (women) or = 13 g/dL (men) at the anesthesia assessment • Platelet count between 150 × 10³/L and 500 × 10³/L • Prothrombin time = 70% and aPTT ratio < 1.2 • Written informed consent

Exclusion criteria

Exclusion criteria: • Congenital or acquired coagulopathy • Use of anticoagulants or ongoing antiplatelet therapy • History of thromboembolic disease • Renal impairment (creatinine > 120 µmol/L) • Hepatic dysfunction (ALT > 3× normal) • Coronary artery disease with stent • BMI > 40 kg/m² or weight > 100 kg • Pregnancy or breastfeeding • Hypersensitivity to fibrinogen or tranexamic acid

Design outcomes

Primary

MeasureTime frame
Percentage decrease in hemoglobin concentration (%?Hb)—

Secondary

MeasureTime frame
• Perioperative blood loss (estimated and visible) ;• Red blood cell transfusion (yes/no and volume) ;• Surgeon-reported intraoperative bleeding ;• Adverse events up to 28 days—

Countries

Tunisia

Contacts

Public ContactMohamed Soussi

University of Sousse Faculty of Medicine of Sousse Sahloul hospital Department of Anesthesia and Reanimation 4011 Sousse Tunisia

mohamed.soussidoc@gmail.com21699210080

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026