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Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. Most trials in orthopedic surgery have been conducted in arthroplasty, hip fracture and spine surgeries. This study would aim to see the effect of tranexamic acid in reduction of blood loss and transfusions for long bone fracture surgery, primarily fracture shaft of femur.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Tranexamic Acid plus standard of care |
|
| B | Other | Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid plus standard of care | Drug | Tranexamic acid given slowly intravenously (15 mg/kg body weight) 15 minutes before surgery followed by a second dose at three hour interval from first dose and third dose at three hour interval from the second + Standard of care (Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss) |
| Measure | Description | Time Frame |
|---|---|---|
| Total Blood Loss | Total blood loss was defined as the sum of intra-operative and post-operative blood loss. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed. | Baseline through Day 7 post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-operative Blood Loss | Intra-operative blood loss was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed. | Day 1 (End of surgery) |
| Post-operative Blood Loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Coimbatore | Tamil Nadu | 641009 | India |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tranexamic Acid Plus Standard of Care | Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss). |
| FG001 | Standard of Care | Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tranexamic Acid Plus Standard of Care | Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss). |
| 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 | Total Blood Loss | Total blood loss was defined as the sum of intra-operative and post-operative blood loss. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed. | Full analysis set (FAS) included all participants who were randomized to study treatment and received at least one dose of study medication. | Posted | Mean | Standard Deviation | Milliliters (mL) | Baseline through Day 7 post-surgery |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 Plus Standard of Care | Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 13.0 | Non-systematic Assessment |
The data for hemoglobin levels was planned but not evaluated on the morning of Day 7 post-surgery.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Standard of care | Procedure | Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss |
|
Post-operative blood loss was defined as the sum of the drainage volumes measured over post-operative days 1, 2, and at drain removal. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed. |
| 1, 4, 8 and 24 hours post-surgery |
| Total Blood Loss Assessed by Gross' Formula | Gross's formula for estimating total blood loss: Estimated blood volume*[(Hematocrit initial - Hematocrit final)/ Hematocrit average]; where estimated blood volume equals body weight in kilograms (kg) *70 mL/kg. | Day 7 post-surgery |
| Number of Participants Receiving Transfusions | A uniform transfusion protocol was maintained for all participants in the study. Transfusion to be triggered at 8.0 milligram/deciliter (mg/dl) hemoglobin or haematocrit value of 24 percent. | Up to day 7 post-surgery |
| Change From Baseline in Hemoglobin Levels at End of Surgery, 1 hr Post-surgery, and Mornings of Day 1, Day 2, Day 4, Day 7 or Early Termination (ET) Post-surgery | Baseline through end of surgery, 1 hr post-surgery, and mornings of Day 1, Day 2, Day 4, Day 7 or ET post-surgery |
| Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery | DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling and warmth. | Day 5 post-surgery |
| Other |
|
| Randomized, but not treated |
|
| BG001 | Standard of Care | Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Standard of Care | Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss. |
|
|
|
| Secondary | Intra-operative Blood Loss | Intra-operative blood loss was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed. | FAS included all participants who were randomized to study treatment and received at least one dose of study medication. | Posted | Mean | Standard Deviation | mL | Day 1 (End of surgery) |
|
|
|
|
| Secondary | Post-operative Blood Loss | Post-operative blood loss was defined as the sum of the drainage volumes measured over post-operative days 1, 2, and at drain removal. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed. | FAS included all participants who were randomized to study treatment and received at least one dose of study medication. | Posted | Mean | Standard Deviation | mL | 1, 4, 8 and 24 hours post-surgery |
|
|
|
|
| Secondary | Total Blood Loss Assessed by Gross' Formula | Gross's formula for estimating total blood loss: Estimated blood volume*[(Hematocrit initial - Hematocrit final)/ Hematocrit average]; where estimated blood volume equals body weight in kilograms (kg) *70 mL/kg. | FAS included all participants who were randomized to study treatment and received at least one dose of study medication. | Posted | Mean | Standard Deviation | mL | Day 7 post-surgery |
|
|
|
|
| Secondary | Number of Participants Receiving Transfusions | A uniform transfusion protocol was maintained for all participants in the study. Transfusion to be triggered at 8.0 milligram/deciliter (mg/dl) hemoglobin or haematocrit value of 24 percent. | FAS included all participants who were randomized to study treatment and received at least one dose of study medication. | Posted | Number | 95% Confidence Interval | Participants | Up to day 7 post-surgery |
|
|
|
|
| Secondary | Change From Baseline in Hemoglobin Levels at End of Surgery, 1 hr Post-surgery, and Mornings of Day 1, Day 2, Day 4, Day 7 or Early Termination (ET) Post-surgery | FAS included all participants who were randomized to study treatment and received at least one dose of study medication. | Posted | Mean | Standard Deviation | gram/deciliter (g/dl) | Baseline through end of surgery, 1 hr post-surgery, and mornings of Day 1, Day 2, Day 4, Day 7 or ET post-surgery |
|
|
|
|
| Secondary | Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery | DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling and warmth. | FAS included all participants who were randomized to study treatment and received at least one dose of study medication. | Posted | Number | 95% Confidence Interval | Participants | Day 5 post-surgery |
|
|
|
|
| 4 |
| 41 |
| 28 |
| 41 |
| EG001 | Standard of Care | Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss. | 1 | 40 | 26 | 40 |
| Fat embolism | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D019984 |
| Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| 8 hours |
|
| 24 hours |
|
|
For 4 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance. |
| t-test, 2 sided |
| 0.045 |
| Mean Difference (Final Values) |
| -6.8 |
| Standard Error of the Mean |
| 3.24 |
| 2-Sided |
| 95 |
| -13.4 |
| -0.1 |
| No |
| Superiority or Other |
| For 8 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance. | t-test, 2 sided | 0.119 | Mean Difference (Final Values) | -6.8 | Standard Error of the Mean | 4.20 | 2-Sided | 95 | -15.4 | 1.8 | No | Superiority or Other |
| For 24 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance. | t-test, 2 sided | 0.139 | Mean Difference (Final Values) | -22.7 | Standard Error of the Mean | 15.16 | 2-Sided | 95 | -52.9 | 7.5 | No | Superiority or Other |
| Change at 1 hour post-surgery |
|
| Change at day 1 post-surgery |
|
| Change at day 2 post-surgery |
|
| Change at day 4 post-surgery or ET |
|
| For change at 1 hour post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements. | Mixed Models Analysis | 0.682 | Least square means difference | 0.10 | Standard Error of the Mean | 0.255 | 2-Sided | 95 | -0.40 | 0.61 | No | Superiority or Other |
| For change at day 1 post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements. | Mixed Models Analysis | 0.569 | Least square means difference | 0.14 | Standard Error of the Mean | 0.244 | 2-Sided | 95 | -0.35 | 0.63 | No | Superiority or Other |
| For change at day 2 post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements. | Mixed Models Analysis | 0.413 | Least square means difference | 0.20 | Standard Error of the Mean | 0.249 | 2-Sided | 95 | -0.29 | 0.70 | No | Superiority or Other |
| For change at day 4/ET post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements. | Mixed Models Analysis | 0.686 | Least square means difference | 0.11 | Standard Error of the Mean | 0.276 | 2-Sided | 95 | -0.44 | 0.66 | No | Superiority or Other |