The Effect of Fibrinogen Injection on Bleeding in Total Knee Arthroplasty

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190222042803N1

Enrollment

Registered

2019-03-10

Start date

2019-02-20

Completion date

Unknown

Last updated

2019-03-25

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

Conditions

Total Knee Arthroplasty. Loose body in knee

Interventions

Intervention 1: Intervention group: Local injection of 500 mg of fibrinogen dissolved powder manufactured by CSL Behring USA in 10 ml of normal saline in the knee joint 2 minutes before opening tourni

Eligibility

Sex/Gender

All

Age

40 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients candidate of Total Knee Arthroplasty (TKA) Age group 40-70 years American Society of Anesthesiologists (ASA) classification I , II

Exclusion criteria

Exclusion criteria: Patients with cardiovascular diseases Patients with anemia or bleeding disorders Consumption of Anticoagulant medications History of knee arthroscopy History of deep vein thrombosis High Body Mass Index

Design outcomes

Primary

Measure	Time frame
Post-operative bleeding. Timepoint: 0, 6 and 24 hours after surgery. Method of measurement: Blood volume in Hemovac.	—

Secondary

Measure	Time frame
Hemoglobin. Timepoint: 0, 6 and 24 hours after surgery. Method of measurement: Blood test.;Prothrombin time (PT). Timepoint: 0, 6 and 24 hours after surgery. Method of measurement: Blood test.;Partial thromboplastin time (PTT). Timepoint: 0, 6 and 24 hours after surgery. Method of measurement: Blood test.;Hematocrit (HCT). Timepoint: 0, 6 and 24 hours after surgery. Method of measurement: Blood test.;Plasma level of fibrinogen. Timepoint: 0, 6 and 24 hours after surgery. Method of measurement: Blood test.	—

Measure

Time frame

Hemoglobin. Timepoint: 0, 6 and 24 hours after surgery. Method of measurement: Blood test.;Prothrombin time (PT). Timepoint: 0, 6 and 24 hours after surgery. Method of measurement: Blood test.;Partial thromboplastin time (PTT). Timepoint: 0, 6 and 24 hours after surgery. Method of measurement: Blood test.;Hematocrit (HCT). Timepoint: 0, 6 and 24 hours after surgery. Method of measurement: Blood test.;Plasma level of fibrinogen. Timepoint: 0, 6 and 24 hours after surgery. Method of measurement: Blood test.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHojatollah Khadem Ali

Ahvaz University of Medical Sciences

Khademhojjat18@gmail.com+98 61333743037

Outcome results

None listed

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