Arthrosis
Conditions
Keywords
Arthroplasty, Replacement, Knee, Tranexamic Acid, Drug Administration Routes
Brief summary
This clinical trial investigated two different routes of administration of tranexamic acid in total knee arthroplasty: topical compared to intravenous.
Detailed description
Intravenous administration of tranexamic acid (TA) is common in orthopedic surgery. The ideal dose and administration route of the drug in total knee arthroplasty (TKA) is under investigation. The objective of this randomized clinical trial was to verify differences between topical and intravenous administration of TA in TKA regarding blood loss and coagulation variables. Patients undergoing TKA were randomized to receive TA intravenously (20 mg in 100 ml of saline), topically (1.5 g in 50 ml of saline, sprayed over the operated site, before closure) or intravenous saline (100 ml). Suction drains were maintained for 48 hours, in order to measure blood loss. Data analysis is being undertaken now, in order to compare the two routes of administration of the drug.
Interventions
DRUGTranexamic Acid - topical
Tranexamic acid is an antifibrinolytic agent that decreases perioperative blood loss, because it inhibits fibrinolysis by competing with lysine molecule in coupling sites in fibrinogen. In this study arm, the drug is administered topically on the wound.
DRUGPlacebo
100 ml of saline solution administered with anesthesia during 10 minutes
DRUGTranexamic Acid - intravenous
Tranexamic acid is an antifibrinolytic agent that decreases perioperative blood loss, because it inhibits fibrinolysis by competing with lysine molecule in coupling sites in fibrinogen. In this arm, the drug is administered intravenously.
Sponsors
Irmandade da Santa Casa de Misericordia de Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients in need of unilateral total knee arthroplasty (TKA) due to arthrosis, Albach grades III and IV were eligible
Exclusion criteria
* history or identified risk for deep vein thrombosis or pulmonary embolism * history of coagulation or cardiovascular disorders * vascular diseases * pregnancy * current use of anticoagulation drugs * previous orthopedic surgery in the legs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss | up to 48 hours from the end of surgery, with drained volume registered every 6 hours. | Volume of blood loss in the suction drain device after TKA surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thrombosis | up to 15 days after surgery | Patients with events of thrombosis after TKA |
| Need for transfusion | during or after surgery, during hospital stay (hospital discharge took place in four days, in average) | Number (or percentage) of patients requiring transfusion in TKA surgery |
Outcome results
None listed