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| ID | Type | Description | Link |
|---|---|---|---|
| 0546934781 | Other Identifier | UCHC |
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| Name | Class |
|---|---|
| Orthopedic Research and Education Foundation | OTHER |
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This study is a double-blinded placebo-controlled clinical trial evaluating the efficacy of 1 gram of topically applied tranexamic acid vs. saline placebo for the reduction of transfusion following hip hemiarthroplasty surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid | Experimental | Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space. |
|
| Placebo | Placebo Comparator | Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug |
| ||
| Placebo (saline) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Needed Transfusions | The rate of transfusion will be calculated for each study group. | From the time of surgery until 2-4 days post-operative (length of inpatient hospital stay) |
| Measure | Description | Time Frame |
|---|---|---|
| Inpatient Transfusion Amount | The transfusion amount will be calculated for each study group. | 2-4 days post-operative (length of inpatient hospital stay) |
| Difference Between Pre/Post-operative Hemoglobin |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | United States | ||
| Saint Francis Hospital and Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tranexamic Acid | Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space. Tranexamic Acid |
| FG001 | Placebo | Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space. Placebo (saline) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tranexamic Acid | Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space. Tranexamic Acid |
| 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 Needed Transfusions | The rate of transfusion will be calculated for each study group. | Posted | Count of Participants | Participants | From the time of surgery until 2-4 days post-operative (length of inpatient hospital stay) |
|
6 weeks
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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 will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space. Tranexamic Acid |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| inpatient treatment for myocardial infarction | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 1 readmission for a fall with a contralateral hip fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vincent Williams, M.D. | UConn Health | (860) 679-8384 | vwilliams@uchc.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 | Nov 19, 2018 | May 14, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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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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|
| Pre-operative hemoglobin level vs. post-operative day 1 hemoglobin level |
| Difference Between Pre/Post-operative Hematocrit | Pre-operative hematocrit level vs. post-operative day 1 hematocrit level |
| Length of Inpatient Hospital Stay | From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever comes first, assessed up to 42 days post-operatively |
| Number of Participants With Post-operative Complications | Admission to second post-operative visit (4-6 weeks post-operative) |
| Inpatient Hospitalization Cost | Collected 4-6 weeks post-operative |
| Hartford |
| Connecticut |
| 06105 |
| United States |
| BG001 | Placebo | Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space. Placebo (saline) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Inpatient Transfusion Amount | The transfusion amount will be calculated for each study group. | Posted | Mean | Standard Deviation | unit of blood (250 cc) | 2-4 days post-operative (length of inpatient hospital stay) |
|
|
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| Secondary | Difference Between Pre/Post-operative Hemoglobin | Posted | Mean | 95% Confidence Interval | grams per deciliter | Pre-operative hemoglobin level vs. post-operative day 1 hemoglobin level |
|
|
|
| Secondary | Difference Between Pre/Post-operative Hematocrit | Posted | Mean | 95% Confidence Interval | percent of blood that is red blood cells | Pre-operative hematocrit level vs. post-operative day 1 hematocrit level |
|
|
|
| Secondary | Length of Inpatient Hospital Stay | Posted | Mean | Standard Deviation | days | From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever comes first, assessed up to 42 days post-operatively |
|
|
|
| Secondary | Number of Participants With Post-operative Complications | Posted | Count of Participants | Participants | Admission to second post-operative visit (4-6 weeks post-operative) |
|
|
|
| Secondary | Inpatient Hospitalization Cost | Data was not gathered for this outcome measure and therefore never analyzed. | Posted | Collected 4-6 weeks post-operative |
|
|
| 0 |
| 17 |
| 1 |
| 17 |
| 6 |
| 17 |
| EG001 | Placebo | Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space. Placebo (saline) | 0 | 19 | 2 | 19 | 11 | 19 |
| demand ischemia | Cardiac disorders | Systematic Assessment |
|
| acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| venous thrombosis | Vascular disorders | Systematic Assessment |
|
| ileus | Gastrointestinal disorders | Systematic Assessment |
|
| atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| altered mental state | Psychiatric disorders | Systematic Assessment |
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| syncope | Cardiac disorders | Systematic Assessment |
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| hypertension | Cardiac disorders | Systematic Assessment |
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| agitation | Psychiatric disorders | Systematic Assessment |
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| urinary retention | Renal and urinary disorders | Systematic Assessment |
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| vomiting | Gastrointestinal disorders | Systematic Assessment |
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| fever | General disorders | Systematic Assessment |
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| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| foley catheter | Renal and urinary disorders | Systematic Assessment |
|
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| D025981 |
| Hip Injuries |
| D007869 | Leg Injuries |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |