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A randomized, prospective, placebo-controlled study which aims to evaluate the effect of combined intraarticular and intravenous Tranexamic acid on total blood loss following unilateral knee replacement versus only intravenous tranexamic acid.
Intravenous (IV) Tranexamic acid is already well-established and well-documented regarding significant effect on reducing blood loss following knee replacement. A few studies more shown a similar effect of intraarticular (IA) injected Tranexamic acid into the knee joint at the end of surgery for knee replacement.
In this study investigators therefore investigate the possible combined effect of added intraarticular tranexamic acid to conventional intravenous Tranexamic acid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IA Tranexamic acid + IV Tranexamic Acid | Active Comparator | 3 gram of Tranexamic acid diluted into 30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery. |
|
| IA Saline Water + IV tranexamic Acid | Placebo Comparator | 30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | An anti-fibrinolytic drug injected into the knee joint at the end of surgery, 3 g diluted in 30 ml saline water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total estimated blood loss | 24 hours surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total estimated blood loss | 2 days after surgery | |
| Thromboembolic complications | 90 days followup for thromboembolic complications. | 90 days postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henrik Husted, PhD | Hvidovre University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre University Hospital | Hvidovre | Denmark |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D019106 | Postoperative Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000068357 | Saline Waters |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Saline water | Drug | 30 ml of Saline water injected into the knee capsula at the end of surgery. |
|
|
| Tranexamic Acid | Drug | An anti-fibrinolytic drug injected intravenous at the beginning of surgery for BOTH groups. |
|
|
| Blood transfusion | Estimate the extent of blood transfusions during admission and readmission in relation to the knee replacement | while hospitalized expected 3 days. |
| D004777 |
| Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |