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The goal of this randomized controlled, double-blinded trial is to assess the efficacy of intravenous tranexamic acid, a drug, in reducing blood loss and transfusion in patients undergoing periacetabular osteotomy, an elective reorientation procedure for the hip joint. The investigators hypothesize that tranexamic acid will be more effective than placebo (normal saline solution) in reducing blood loss and transfusion after periacetabular osteotomy.
Periacetabular osteotomy (PAO) is an elective reorientation surgery for the hip joint, typically for the treatment of hip dysplasia in young, otherwise healthy patients, which requires multiple pelvic osteotomies around the acetabulum. A major source of its perioperative morbidity is blood loss. The principal cause of postoperative blood loss after PAO is surgical trauma, with secondary activation of both the coagulation cascade and local fibrinolysis. In the PAO literature, allogeneic transfusion rates are as high as 58%, and blood loss can range to nearly 4 L. The risk of excessive blood loss and blood transfusion in young, healthy patients after elective surgery is an event that can be reduced with blood conservation protocols, which can include pharmacological agents. Tranexamic acid is a synthetic derivative of the amino acid lysine and a competitive inhibitor of plasminogen activation that interferes with fibrinolysis. Multiple studies and meta-analyses have shown that intravenous administration of the antifibrinolytic agent tranexamic acid reduces postoperative bleeding and the need for transfusion during joint replacement surgery. However, no published data exists to support its use during PAO. We hypothesize that intravenous tranexamic acid will reduce perioperative blood loss and, thus, transfusion requirement in patients undergoing PAO. A total of 80 patients will be enrolled. Patients will be randomized to receive either intravenous tranexamic acid versus placebo (normal saline) during PAO. Calculated total blood loss (primary outcome) will be determined, and intraoperative cell saver utilization (secondary outcome), and (3) postoperative allogeneic blood transfusion (secondary outcome) will be recorded. Patients will be followed for a total of 6 weeks after surgical intervention. If the use of IV tranexamic acid in the PAO patient population significantly reduces total perioperative blood loss, then it would provide an efficacious and inexpensive method for reducing postoperative morbidity after PAO.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid | Experimental | Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively. |
|
| Placebo | Placebo Comparator | Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Medication administered intra-operatively to promote blood clotting. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Calculated Total Blood Loss | Calculated total blood loss by patients | 1day (Hospital Admission) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Allogenic Blood Transfusion | Total allogenic blood transfusion | 1day (Hospital Admission) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ernest L. Sink, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tranexamic Acid | Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively. Tranexamic Acid |
| FG001 | Placebo | Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively. Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tranexamic Acid | Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively. Tranexamic Acid |
| BG001 | Placebo | Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively. Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Calculated Total Blood Loss | Calculated total blood loss by patients | Posted | Mean | Full Range | mL | 1day (Hospital Admission) |
|
|
Adverse event data was collected through study completion, up to 6 weeks
Only serious venous thromboembolic complications were monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tranexamic Acid | Patients randomized to this arm will receive standard dosing of tranexamic acid intraoperatively. Tranexamic Acid |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ernest Sink | Hospital for Special Surgery | 2126061279 | Sinke@hss.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 14, 2013 | Apr 13, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006618 | Hip Dislocation, Congenital |
| ID | Term |
|---|---|
| D000082602 | Developmental Dysplasia of the Hip |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Saline solution |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Number of Patients With Allogenic Blood Transfusion | Total allogenic blood transfusion | Posted | Number | participants | 1day (Hospital Admission) |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Placebo | Patients randomized to this arm will receive normal saline solution, instead of tranexamic acid, intraoperatively. Placebo | 0 | 41 | 0 | 41 | 0 | 41 |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |