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The goal of this Randomized controlled trial is to evaluate in household ambulatory, elderly patients sustaining femoral neck fracture who are subjected to be treat with cementless bipolar hemiarthroplasty. The main questions it aims to answer are:
As having undergone bipolar hemiarthroplasty surgery, participants will either receive retrograde intraarticular tranexamic acid injection via drain tube, or topical soaking administration.
Researchers will compare, with standard procedure (procedure), whether topically administered tranexamic acid would reduce rate of blood transfusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrograde Intraarticular Injection via Drain Tube | Experimental | Tranexamic acid will be injected retrograde to the joint via drain tube after surgical wound closure |
|
| Topical Soaking of Tranexamic Acid | Experimental | Tranexamic acid will be placed to soak the intramedullary canal of the femur and surgical area after sheath closure for 5 minutes and completely remove by sunction |
|
| Standard procedure (placebo) | Placebo Comparator | Standard wound irrigation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical tranexamic acid administration | Drug | Tranexamic acid will be topically administered in intervention groups |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of blood transfusion | Proportion of patients received blood transfusion divided by total number of patient in a group | 2 years, or until complete enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of blood transfusion | total volume of blood transfusion per each patient | 2 years, or until complete enrollment |
| Calculated blood loss | Calculating using Nadler and Goss formula |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kanyakorn Riewruja, Medical degree | Contact | +66958644447 | kanyakorn.riew@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, King Chulalongkorn Memorial Hospital | Recruiting | Bangkok | 10330 | Thailand |
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| 2 years, or until complete enrollment |
| Any adverse events | Adverse events include wound complication, deep vein thrombosis, pulmonary embolism, and other complication | 2 years, or until complete enrollment |
| In-hospital mortality | In-hospital mortality | During admission period |
| Faculty of Medicine | Not yet recruiting | Bangkok | 10330 | Thailand |
|
| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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