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Does tranexamic acid improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.
Antifibrinolytic medications such as tranexamic acid, aprotinin, and aminocaproic acid have proven to be useful in decreasing blood loss and the proportion of patients who require transfusion after a number of surgical procedures. In orthopedic surgery, tranexamic acid (TXA) is the best studied of these medications and a recent Cochrane Database review determined that tranexamic acid was effective in decreasing perioperative bleeding and post-operative transfusion after elective hip replacement and knee replacement surgery. At Mayo Clinic Rochester, the routine administration of tranexamic acid has evolved over the past decade to become part of the typical protocol for more than 3,000 elective hip and knee replacement procedures each year. Recent administrative data provides fairly compelling evidence of the efficacy of tranexamic acid in decreasing transfusion at the Mayo Clinic Rochester practice with 2010 data showing 2% and 7% prevalence of transfusion in patients treated with tranexamic acid versus 18% and 33% prevalence in those knee and hip replacement patients, respectively, who were not treated with tranexamic acid. A recent analysis of the Mayo Clinic Rochester orthopedic practice showed that patients treated for hip fracture remain at substantial risk of perioperative transfusion (30% prevalence) after operative management. This raises the question as to whether tranexamic acid could improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. |
|
| tranexamic acid | Active Comparator | Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tranexamic acid | Drug | Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Received a Hospitalization Transfusion | Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Units Transfused | Mean number of units transfused per patient | 5 days |
| Calculated Blood Loss | Calculated blood loss | 5 days |
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Inclusion criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Mark Pagnano, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. placebo: A similar dose of 0.9% sodium chloride (NaCL) will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure. |
| FG001 | Tranexamic Acid | Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Who Received a Hospitalization Transfusion | Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission | Posted | Number | participants | 5 days |
|
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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 | Placebo | Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MI | Cardiac disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Readmission | Surgical and medical procedures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Pagnano | Mayo Clinic | 507-284-2511 | pagnano.mark@mayo.edu |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| placebo | Drug | A similar dose of 0.9% sodium chloride (NaCL) will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure. |
|
| Number of Participants With Venous Thromboembolism (VTE) Diagnosis | Incidence of symptomatic VTE diagnosed within 6 months of surgery | Within 6 months of surgery |
| Number of Participants With Wound Complications | Wound complications diagnosed within 6 months of surgery | Within 6 months of surgery |
| Number of Participants With Myocardial Infarction (MI) Diagnosis | MI diagnosed within 6 months of surgery | Within 6 months of surgery |
| Number of Participants With Cerebrovascular Accident (CVA) Diagnosis | CVA diagnosed within 6 months of surgery | Within 6 months of surgery |
| Number of Participants Who Died | All-cause mortality at 6 months | 6 months after surgery |
| BG001 | Tranexamic Acid | Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Mean Number of Units Transfused | Mean number of units transfused per patient | Posted | Mean | Standard Deviation | units/participant transfused | 5 days |
|
|
|
| Secondary | Calculated Blood Loss | Calculated blood loss | Posted | Mean | Standard Deviation | cc | 5 days |
|
|
|
| Secondary | Number of Participants With Venous Thromboembolism (VTE) Diagnosis | Incidence of symptomatic VTE diagnosed within 6 months of surgery | Posted | Number | participants | Within 6 months of surgery |
|
|
|
| Secondary | Number of Participants With Wound Complications | Wound complications diagnosed within 6 months of surgery | Posted | Number | participants | Within 6 months of surgery |
|
|
|
| Secondary | Number of Participants With Myocardial Infarction (MI) Diagnosis | MI diagnosed within 6 months of surgery | Posted | Number | participants | Within 6 months of surgery |
|
|
|
| Secondary | Number of Participants With Cerebrovascular Accident (CVA) Diagnosis | CVA diagnosed within 6 months of surgery | Posted | Number | participants | Within 6 months of surgery |
|
|
|
| Secondary | Number of Participants Who Died | All-cause mortality at 6 months | Posted | Number | participants | 6 months after surgery |
|
|
|
|
| 15 |
| 69 |
| 9 |
| 69 |
| EG001 | Tranexamic Acid | Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. | 14 | 69 | 15 | 69 |
| CVA | Nervous system disorders |
|
| Death | Surgical and medical procedures |
|
| VTE | Blood and lymphatic system disorders |
|
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