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The purpose of this study is to determine the relative effectiveness of two drug agents, Tranexamic acid (TXA) and aminocaproic acid (Amicar), that act through a similar mechanism of action. These agents are used to decrease blood loss that is a result of major surgery, like total joint arthroplasty. A secondary goal will be investigate the cost-analysis of total hospitalization. Both TXA and Amicar are both currently used in the care of patients undergoing total joint arthroplasty.
Subjects will be randomly assigned to the TXA or Amicar arm. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization stay.
Our Hypothesis is that TXA and Amicar will have similar effectiveness in preventing intraoperative blood loss and the need for transfusion post-op than Amicar.
A detailed cost analysis will show that the overall cost of performing the operative procedure, including transfusions, OR time, and total costs associated with admission cost will be more decreased with Amicar as compared to TXA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid (TXA) | Active Comparator | TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for Total Knee Arthroplasties (TKAs) and Total Hip Arthroplasties (THAs) per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization. |
|
| Epsilon-aminocaproic acid (Amicar) | Active Comparator | Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for Total Knee Arthroplasties (TKAs) and Total Hip Arthroplasties (THAs) per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amicar | Drug | Subjects randomized to receive Amicar will receive this during surgical intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge) | Participants will be followed for the duration of hospital stay, an expected average of 5 days | |
| Number of Transfusions | Participants will be followed for the duration of hospital stay, an expected average of 5 days | |
| Difference in Preoperative and Lowest Postoperative Hemoglobin | Participants will be followed for the duration of hospital stay, an expected average of 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospitalization Stay | Participants will be followed for the duration of hospital stay, an expected average of 5 days | |
| Cost of Hospitalization | Participants will be followed for the duration of hospital stay, an expected average of 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27708 | United States |
Patients were excluded from the trial after enrollment if their surgery was cancelled.
Consenting completed at PI and co-investigators' private offices, clinic and in preoperative center. Study staff approved by the IRB consent the patients. First patient enrolled in January 2015. Last patient enrolled on 11/12/17.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tranexamic Acid (TXA) - Total Hip Arthroplasty | TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization. TXA: Subjects randomized to receive TXA will receive this during surgical intervention |
| FG001 | Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty | Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization. Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention |
| FG002 | Tranexamic Acid (TXA) - Total Knee Arthroplasty | TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization. TXA: Subjects randomized to receive TXA will receive this during surgical intervention |
| FG003 | Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty | Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization. Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects who completed the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Tranexamic Acid (TXA) - Total Hip Arthroplasty | TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization. TXA: Subjects randomized to receive TXA will receive this during surgical intervention |
| 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 | Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge) | Posted | Median | Inter-Quartile Range | milliliters | Participants will be followed for the duration of hospital stay, an expected average of 5 days |
|
Within 90 days of surgery
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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 (TXA) - Total Hip Arthroplasty | TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization. TXA: Subjects randomized to receive TXA will receive this during surgical intervention |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Superficial Cellulitis | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Bolognesi, M.D. | Duke University | 919-668-4732 | michael.bolognesi@duke.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 | Jan 15, 2015 | Oct 24, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015119 | Aminocaproic Acid |
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D000614 | Aminocaproates |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| TXA | Drug | Subjects randomized to receive TXA will receive this during surgical intervention |
|
|
| BG001 | Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty | Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization. Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention |
| BG002 | Tranexamic Acid (TXA) - Total Knee Arthroplasty | TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization. TXA: Subjects randomized to receive TXA will receive this during surgical intervention |
| BG003 | Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty | Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization. Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization. Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention |
| OG002 | Tranexamic Acid (TXA) - Total Knee Arthroplasty | TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization. TXA: Subjects randomized to receive TXA will receive this during surgical intervention |
| OG003 | Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty | Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization. Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention |
|
|
|
| Primary | Number of Transfusions | Posted | Number | transfusions | Participants will be followed for the duration of hospital stay, an expected average of 5 days |
|
|
|
|
| Primary | Difference in Preoperative and Lowest Postoperative Hemoglobin | Posted | Median | Inter-Quartile Range | grams per deciliter | Participants will be followed for the duration of hospital stay, an expected average of 5 days |
|
|
|
|
| Secondary | Length of Hospitalization Stay | Posted | Median | Inter-Quartile Range | days | Participants will be followed for the duration of hospital stay, an expected average of 5 days |
|
|
|
|
| Secondary | Cost of Hospitalization | Data not collected. | Posted | Participants will be followed for the duration of hospital stay, an expected average of 5 days |
|
|
| 0 |
| 46 |
| 3 |
| 46 |
| 3 |
| 46 |
| EG001 | Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty | Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization. Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention | 0 | 44 | 0 | 44 | 1 | 44 |
| EG002 | Tranexamic Acid (TXA) - Total Knee Arthroplasty | TXA will be administered as a 1 gm dose IV prior to the procedure then as a repeat dose of 1 gram at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization. TXA: Subjects randomized to receive TXA will receive this during surgical intervention | 0 | 73 | 3 | 73 | 1 | 73 |
| EG003 | Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty | Administered 5g in 250mL of IV normal saline over 15 minutes prior to the procedure and then an infusion of 5g at the time of wound closure. These doses are currently used at Duke for TKAs and THAs per standard of care by the orthopaedic team. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization. Amicar: Subjects randomized to receive Amicar will receive this during surgical intervention | 0 | 72 | 0 | 72 | 1 | 72 |
| NSTEMI | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Deep Infection | Infections and infestations | Non-systematic Assessment |
|
| Hematoma/Seroma | General disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D009930 |
| Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |