Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609861307035 Date of Registration: 04/09/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Prophylactic fibrinogen infusion to reduce blood loss in multilevel lumbar spinal fusion.
Official scientific title Prophylactic Fibrinogen Infusion in Multilevel Spinal Fusion (PFI/MSF): A Randomized Controlled Trial.
Brief summary describing the background and objectives of the trial Multilevel lumbar spinal fusion (MSF) is associated with moderate to high intraoperative blood loss and significant transfusion requirements. Perioperative bleeding is often diffuse and predominantly venous, making it difficult to control. Despite optimization strategies that include patient blood management (PBM) and the use of tranexamic acid (TXA), blood loss remains substantial in MSF. Fibrinogen (Fg) plays a key role in coagulation as a precursor of fibrin, which stabilizes the clot. Administration of prophylactic fibrinogen has demonstrated efficacy in reducing blood loss in cardiac, orthopedic, and major urologic surgeries. However, evidence in spinal surgery is limited and existing trials have not evaluated fibrinogen in combination with TXA, which is currently standard of care. This randomized controlled trial aims to compare the effectiveness of prophylactic fibrinogen combined with tranexamic acid versus tranexamic acid alone in reducing a ≥ 20% decrease in hemoglobin levels in adult patients undergoing multilevel lumbar spinal fusion. Secondary objectives include quantifying perioperative blood loss, comparing perioperative red blood cell transfusion rates between the two groups, and assessing the safety of prophylactic fibrinogen administration.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PFI/MSF
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2023
Actual trial start date 07/02/2023
Anticipated date of last follow up 31/12/2024
Actual Last follow-up date 22/03/2025
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants) 52
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
H6XJF OSF
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation Sequence/Code was not concealed Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control Tranexamic acid (ATX): 1 g diluted in 250 mL normal saline, Only one dose Administered intravenously 30 minutes before surgery 26 Active-Treatment of Control Group
Experimental Group Fibrinogen - Fibrinogen concentrate (Haemocomplettan® P): 1 g diluted in 50 mL normal saline, - Plus tranexamic acid (same protocol as control group) Only one dose Administered intravenously 30 minutes before surgery 26
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• 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 • 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 Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/12/2022 Ethics Committee of the Faculty of Medicine of Sousse
Ethics Committee Address
Street address City Postal code Country
Rue Mohamed Karoui Sousse Sousse 4002 Tunisia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/11/2022 Comite d ethique de CHU Sahloul Sousse
Ethics Committee Address
Street address City Postal code Country
route de ceinture, Sahloul Sousse 4011 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Percentage decrease in hemoglobin concentration (%ΔHb) Period: from the start of the procedure until the first postoperative day, 24 hours after
Secondary Outcome • Perioperative blood loss (estimated and visible) Period: from the start of the procedure until the first postoperative day, 24 hours after
Secondary Outcome • Red blood cell transfusion (yes/no and volume) Period: from the start of the procedure until the first postoperative day, 24 hours after
Secondary Outcome • Surgeon-reported intraoperative bleeding Period: from the start of the procedure until the first postoperative day, 24 hours after
Secondary Outcome • Adverse events up to 28 days 28 days after the surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sahloul University Hospital Center Route de la Ceinture Sahloul Hammam Sousse 4011 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Sahloul Hospital Route de ceinture, sahloul Hammam Sousse 4011 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Departement of anesthesiology Sahloul hospital Route de centure, Sahloul Hammam sousse 4011 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Department of Anesthesiology sahloul Route de ceinture, Sahloul Hammam Sousse 4011 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Souha Guellim souha.guellim@famso.u-sousse.tn 21697848870 Route de ceinture sahloul
City Postal code Country Position/Affiliation
Hammam sousse 4011 Tunisia University of Sousse Faculty of Medicine of Sousse Sahloul hospital Department of Anesthesia and Reanimation 4011 Sousse Tunisia
Role Name Email Phone Street address
Public Enquiries Mohamed Soussi mohamed.soussidoc@gmail.com 21699210080 Route de ceinture sahloul
City Postal code Country Position/Affiliation
Hammam sousse 4011 Tunisia University of Sousse Faculty of Medicine of Sousse Sahloul hospital Department of Anesthesia and Reanimation 4011 Sousse Tunisia
Role Name Email Phone Street address
Scientific Enquiries Souha Guellim souha.guellim@famso.u-sousse.tn 21697848870 Route de ceinture sahloul
City Postal code Country Position/Affiliation
Hammam sousse 4011 Tunisia University of Sousse Faculty of Medicine of Sousse Sahloul hospital Department of Anesthesia and Reanimation 4011 Sousse Tunisia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will not be publicly available. Anonymized data may be shared with qualified researchers upon reasonable request and following approval by the relevant ethics committee. Statistical Analysis Plan,Study Protocol Data will be available after publication of the main study results and upon reasonable request. Access will be considered upon reasonable request from qualified researchers with a scientifically valid proposal. Data access will require approval by the study investigators and the relevant ethics committee, and will be limited to anonymized data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 26/08/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 26/08/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 31/07/2026 To add the primary and secondary objectives. Multilevel lumbar spinal fusion (MSF) is associated with moderate to high intraoperative blood loss and significant transfusion requirements. Perioperative bleeding is often diffuse and predominantly venous, making it difficult to control. Despite optimization strategies that include patient blood management (PBM) and the use of tranexamic acid (TXA), blood loss remains substantial in MSF. Fibrinogen (Fg) plays a key role in coagulation as a precursor of fibrin, which stabilizes the clot. Administration of prophylactic fibrinogen has demonstrated efficacy in reducing blood loss in cardiac, orthopedic, and major urologic surgeries. However, evidence in spinal surgery is limited and existing trials have not evaluated fibrinogen in combination with TXA, which is currently standard of care. Multilevel lumbar spinal fusion (MSF) is associated with moderate to high intraoperative blood loss and significant transfusion requirements. Perioperative bleeding is often diffuse and predominantly venous, making it difficult to control. Despite optimization strategies that include patient blood management (PBM) and the use of tranexamic acid (TXA), blood loss remains substantial in MSF. Fibrinogen (Fg) plays a key role in coagulation as a precursor of fibrin, which stabilizes the clot. Administration of prophylactic fibrinogen has demonstrated efficacy in reducing blood loss in cardiac, orthopedic, and major urologic surgeries. However, evidence in spinal surgery is limited and existing trials have not evaluated fibrinogen in combination with TXA, which is currently standard of care. This randomized controlled trial aims to compare the effectiveness of prophylactic fibrinogen combined with tranexamic acid versus tranexamic acid alone in reducing a ≥ 20% decrease in hemoglobin levels in adult patients undergoing multilevel lumbar spinal fusion. Secondary objectives include quantifying perioperative blood loss, comparing perioperative red blood cell transfusion rates between the two groups, and assessing the safety of prophylactic fibrinogen administration.
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 04/09/2026 PACTR Admin Control Group, Control Group, Tranexamic acid (ATX): 1 g diluted in 250 mL normal saline, , Only one dose, Administered intravenously 30 minutes before surgery, 26, Active-Treatment of Control Group Control Group, Control , Tranexamic acid (ATX): 1 g diluted in 250 mL normal saline, , Only one dose, Administered intravenously 30 minutes before surgery, 26, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 31/07/2026 to name the intervention group Experimental Group, intervention Group, - Fibrinogen concentrate (Haemocomplettan® P): 1 g diluted in 50 mL normal saline, - Plus tranexamic acid (same protocol as control group) , Only one dose , Administered intravenously 30 minutes before surgery , 26, Experimental Group, Fibrinogen Group, - Fibrinogen concentrate (Haemocomplettan® P): 1 g diluted in 50 mL normal saline, - Plus tranexamic acid (same protocol as control group) , Only one dose , Administered intravenously 30 minutes before surgery , 26,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 04/09/2026 PACTR Admin Experimental Group, Fibrinogen Group, - Fibrinogen concentrate (Haemocomplettan® P): 1 g diluted in 50 mL normal saline, - Plus tranexamic acid (same protocol as control group) , Only one dose , Administered intravenously 30 minutes before surgery , 26, Experimental Group, Fibrinogen, - Fibrinogen concentrate (Haemocomplettan® P): 1 g diluted in 50 mL normal saline, - Plus tranexamic acid (same protocol as control group) , Only one dose , Administered intravenously 30 minutes before surgery , 26,
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 26/08/2026 The results were available No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 26/08/2026 To present the results because the Trial was completed on March 22, 2025 43768_30886_1045.pdf