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Studying the effect of intra-articular fibrinogen and tranexamic acid on bleeding in knee arthroplasty.

The combined effect of intra-articular fibrinogen and tranexamic acid on postoperative bleeding in total knee arthroplasty

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191013045091N2
Enrollment
60
Registered
2025-12-14
Start date
2025-12-22
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Total Knee Arthroplasty (TKA) Surgery.

Interventions

Intervention 1: Intervention group: In this study, after the patient enters the operating room, all baseline parameters including hemoglobin, hematocrit, international normalized ratio (INR), prothrom

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age between 40-70 years Patients with physical status class I and II according to the American Society of Anesthesiologists classification Candidate patient for total knee arthroplasty Performing surgery under spinal anesthesia

Exclusion criteria

Exclusion criteria: Dissatisfaction with participating in the study History of knee arthroscopic surgery Uncontrolled blood pressure Cardiovascular disease Deep vein thrombosis Coagulation Use of nonsteroidal anti-inflammatory drugs and anticoagulants Body mass index more than 30 Operation time more than 120 minutes

Design outcomes

Primary

MeasureTime frame
Hemoglobin. Timepoint: Before surgery and at the end of the first 24 hours after surgery. Method of measurement: Hematology Analyzer (Cell counter).;Hematocrit. Timepoint: Before surgery and at the end of the first 24 hours after surgery. Method of measurement: Hematology Analyzer (Cell counter).;International Normalized Ratio. Timepoint: Before surgery and at the end of the first 24 hours after surgery. Method of measurement: Obtaining patient blood and measuring prothrombin time. Its standardization against control plasma is calculated using the international sensitivity coefficient.;Platelet. Timepoint: Before surgery and at the end of the first 24 hours after surgery. Method of measurement: Automated hematology machine.;Prothrombin time. Timepoint: Before surgery and at the end of the first 24 hours after surgery. Method of measurement: Coagulometer.;Partial thromboplastin time. Timepoint: Before surgery and at the end of the first 24 hours after surgery. Method of measurement: Coagulation Analyzer.

Secondary

MeasureTime frame
Duration of surgery. Timepoint: The duration of the surgery will be recorded from the start to the end of the procedure. Method of measurement: Reviewing information recorded in the patient's file.;Length of stay. Timepoint: Patient admission time up to 24 hours after the end of the intervention. Method of measurement: Review of patient records.;Amount of bleeding during surgery. Timepoint: Start of surgical incision to end of suture (wound closure). Method of measurement: Suction blood volume.;Bleeding after surgery. Timepoint: Immediately after surgery and the first 24 hours after surgery. Method of measurement: The volume of blood collected in drains or suction after surgery.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Kian Darbani

Shahid Beheshti University of Medical Sciences

Darbanikiands@gmail.com+98 21 2303 1111

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026