Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in various types of major surgery (orthopedic surgery, spine surgery, cardiopulmonary bypass, liver resections, and gynecological cancers).The current trial is being conducted to compare the efficacy of tranexamic acid plus standard of care versus standard of care in reduction of blood loss in patients undergoing major abdominal surgeries.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | end of the operation and on the mornings of the first, second, fourth and seventh postoperative days. |
|
| B | Other | Standard of Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid + 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 |
|---|---|---|
| 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. | Post-operation, Day 1, Day 2 up to drain removal |
| 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) |
| Total Blood Loss |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Surat | Gujarat | 395 001 | India | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
| 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard of Care | Procedure | Standard of care includes the routine surgical and anesthetic techniques being utilized to control 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 2 post-surgery |
| Total Blood Loss as Assessed by the Gross' Formula | Gross' formula for estimating total blood loss: Estimated blood volume multiplied by (*) [(hematocrit initial minus hematocrit final) divided by hematocrit average]; where estimated blood volume equals body weight in kilograms (kg) *70 mL/kg. | Baseline through Day 2 post-surgery |
| Percentage 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 hematocrit value of 24 percent. | Up to Day 7 post-surgery |
| Hemoglobin Levels | End of surgery, Day 1, Day 2, Day 4 and Day 7/End of treatment (EoT) 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 7 post-surgery |
| Vadodara |
| Gujarat |
| 390 001 |
| India |
| FG001 | Standard of Care | Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| 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). |
| 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | 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. | Full Analysis Set (FAS) population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint. | Posted | Mean | Standard Deviation | milliliter (mL) | Post-operation, Day 1, Day 2 up to drain removal |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint. | Posted | Mean | Standard Deviation | mL | Day 1 (End of surgery) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint. | Posted | Mean | Standard Deviation | mL | Baseline through Day 2 post-surgery |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Blood Loss as Assessed by the Gross' Formula | Gross' formula for estimating total blood loss: Estimated blood volume multiplied by (*) [(hematocrit initial minus hematocrit final) divided by hematocrit average]; where estimated blood volume equals body weight in kilograms (kg) *70 mL/kg. | FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint. | Posted | Mean | Standard Deviation | mL | Baseline through Day 2 post-surgery |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage 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 hematocrit value of 24 percent. | FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Day 7 post-surgery |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hemoglobin Levels | FAS population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint. | Posted | Mean | Standard Deviation | Gram/Deciliter (g/dL) | End of surgery, Day 1, Day 2, Day 4 and Day 7/End of treatment (EoT) 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 population included all randomized participants in compliance with the intent-to-treat analysis principle. Participants who had no post-baseline data for a given endpoint was not included in the analysis of that endpoint. | Posted | Number | Participants | Day 7 post-surgery |
|
|
Not provided
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.
Not provided
| 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). | 9 | 49 | 22 | 49 | ||
| EG001 | Standard of Care | Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss. | 7 | 45 | 14 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Biliary tract disorder | Hepatobiliary disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Infectious peritonitis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Biliary anastomosis complication | Injury, poisoning and procedural complications | MedDRA v14.1 | Non-systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA v14.1 | Non-systematic Assessment |
| |
| Suture rupture | Injury, poisoning and procedural complications | MedDRA v14.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Cardiac procedure complication | Injury, poisoning and procedural complications | MedDRA v14.1 | Non-systematic Assessment |
| |
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA v14.1 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v14.1 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Bradykinesia | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Urticaria contact | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v14.1 | Non-systematic Assessment |
|
The intended FAS population was planned to include participants from 2 sites, however due to non-reliability of data from one of the sites, the actual FAS population included participants from a single site only.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Greater than or equal to 65 years |
|
| Male |
|
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
|
| Participants |
|
|