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Tranexamic acid, an antifibrinolytic drug, is wildly used in cardiac surgeries to decrease perioperative bleeding and allogenic transfusion. But the optimum dose of tranexamic acid is still unknown. We use three different doses to find which is the optimum dose of tranexamic acid in cardiopulmonary bypass cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| small dose | Experimental | 10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery |
|
| medium dose | Experimental | 20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery |
|
| large dose | Experimental | 30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | The loading doses were given in 15 minutes when incision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Blood Loss | 24hrs postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Needs Allogenic Transfusion | on the 7th day postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Reexploration for Bleeding | on the 7th day postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongwen Ji, MD | Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC | Study Chair |
| Haisong Lu | Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC | Beijing | Beijing Municipality | 100037 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Small Dose | 10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery Tranexamic Acid: The loading doses were given in 15 minutes when incision. |
| FG001 | Medium Dose | 20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery Tranexamic Acid: The loading doses were given in 15 minutes when incision. |
| FG002 | Large Dose | 30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery Tranexamic Acid: The loading doses were given in 15 minutes when incision. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Small Dose | 10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery Tranexamic Acid: The loading doses were given in 15 minutes when incision. |
| BG001 | Medium Dose |
| 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 | Postoperative Blood Loss | Posted | Median | Inter-Quartile Range | ml | 24hrs postoperatively |
|
7 days postoperative
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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 | Small Dose | 10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery Tranexamic Acid: The loading doses were given in 15 minutes when incision. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| renal dysfunction | Renal and urinary disorders | renal dysfunction | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| wound infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hongwen Ji | Fuwai Hospital | +86 13701229553 | jihongwen@hotmail.com |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D020086 | Short Interspersed Nucleotide Elements |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery Tranexamic Acid: The loading doses were given in 15 minutes when incision. |
| BG002 | Large Dose | 30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery Tranexamic Acid: The loading doses were given in 15 minutes when incision. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery Tranexamic Acid: The loading doses were given in 15 minutes when incision. |
|
|
| Secondary | Number of Participants Needs Allogenic Transfusion | Not Posted | on the 7th day postoperatively |
| Other Pre-specified | Rate of Reexploration for Bleeding | Not Posted | on the 7th day postoperatively |
| 34 |
| 319 |
| 2 |
| 319 |
| EG001 | Medium Dose | 20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery Tranexamic Acid: The loading doses were given in 15 minutes when incision. | 42 | 318 | 3 | 318 |
| EG002 | Large Dose | 30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery Tranexamic Acid: The loading doses were given in 15 minutes when incision. | 29 | 318 | 2 | 318 |
| usage of IABP | Cardiac disorders | Systematic Assessment |
|
| cerebral embolism | Nervous system disorders | Systematic Assessment |
|
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| D018626 |
| Retroelements |
| D020071 | Interspersed Repetitive Sequences |
| D012091 | Repetitive Sequences, Nucleic Acid |
| D001483 | Base Sequence |
| D015394 | Molecular Structure |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D040481 | Genome Components |
| D016678 | Genome |