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This clinical trial investigated two different routes of administration of tranexamic acid in total knee arthroplasty: topical compared to intravenous.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical group | Experimental | Intervention: Tranexamic Acid - topical. Topical administration of a solution of 1.5 g of tranexamic acid (50 mg/ml, Transamin, Zydus Nikkho) diluted in 50 ml of saline (at 0.9%), sprayed over the operated area, covering it for 5 minutes, before the tourniquet release. |
|
| Intravenous group | Active Comparator | Intervention: Tranexamic Acid - intravenous Intravenous injection of 20 mg/kg of tranexamic acid, diluted in 100 ml of saline at 0.9%, administered with anesthesia in 10 minutes. |
|
| Placebo | Placebo Comparator | Intervention: intravenous injection of 100 ml of saline solution also administered with anesthesia in 10 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid - topical | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss | Volume of blood loss in the suction drain device after TKA surgery | up to 48 hours from the end of surgery, with drained volume registered every 6 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Thrombosis | Patients with events of thrombosis after TKA | up to 15 days after surgery |
| Need for transfusion | Number (or percentage) of patients requiring transfusion in TKA surgery |
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Inclusion Criteria: Patients in need of unilateral total knee arthroplasty (TKA) due to arthrosis, Albach grades III and IV were eligible
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zekcer Ari, MD, PhD | Santa Casa de São Paulo | Principal Investigator |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
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| Placebo | Drug | 100 ml of saline solution administered with anesthesia during 10 minutes |
|
|
| Tranexamic Acid - intravenous | Drug | 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. |
|
|
| during or after surgery, during hospital stay (hospital discharge took place in four days, in average) |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |