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The aim of this prospective, randomized, double-blinded, placebo-controlled study was to evaluate the effects of tranexamic acid, a synthetic antifibrinolytic drug, on the postoperative bleeding and transfusion requirements in patients undergoing off-pump coronary artery bypass graphing (OPCAB) surgery.
Cardiac surgical procedures account for a large amount of allogeneic transfusion. Although postoperative bleeding seems to be attenuated by the avoidance of cardiopulmonary bypass (CPB), hemorrhagic complications are not completely eliminated and the consequent need for allogeneic transfusions are still major problems after OPCAB.
Tranexamic acid, a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with CPB. About 30% of patients in OPCAB studies still receive a transfusion. A few small sample size studies concerned with the use of in OPCAB surgery, found that tranexamic acid appear to be effective in reducing postoperative bleeding, however, the results on transfusion requirements are still inconsistency. The purpose of this study was to evaluate the effects of tranexamic acid on the postoperative bleeding and transfusion requirements in a larger number of patients undergoing OPCAB surgery. In addition, the effect of tranexamic acid on mortality, morbidity and resource utilization was examined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid group | Experimental |
| |
| Control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | In tranexamic acid group, tranexamic acid, 1 g, was given 20 minutes before incision and 400 mg/h during the entire surgical procedure. The patients from control group were infused with normal saline as a placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Required Allogenic Red Blood Cells Transfusion | 1month postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Chest Tube Drainage | 24h postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lihuan Li, M.D | Chinese Academy of Medical Sciences, Fuwai Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Institute and Fuwai Hospital | Beijing | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21737704 | Derived | Wang G, Xie G, Jiang T, Wang Y, Wang W, Ji H, Liu M, Chen L, Li L. Tranexamic acid reduces blood loss after off-pump coronary surgery: a prospective, randomized, double-blind, placebo-controlled study. Anesth Analg. 2012 Aug;115(2):239-43. doi: 10.1213/ANE.0b013e3182264a11. Epub 2011 Jul 7. |
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Of the 260 patients randomized, 130 were allocated to each group. 14 patients in tranexamic acid group and 15 in placebo group were withdrawn from the study for convert to on-pump surgery in course of surgery.
From February 2009 to December 2009, 378 consecutive patients in Fuwai hospital scheduled for elective OPCAB were enrolled in the study. 118 patients were excluded for randomizatin because not meeting inclusion criteria(n=29), Refused to participate(n=81),and surgery cancelled(n=8).
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| ID | Title | Description |
|---|---|---|
| FG000 | Tranexamic Acid Group | Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery. |
| FG001 | Control Group | The placebo consisted of an equivalent volume of saline solution. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tranexamic Acid Group | Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Number of Patients Required Allogenic Red Blood Cells Transfusion | As predefined by study protocol,Fourteen patients in the tranexamic acid group and Fifteen in the placebo group were withdrawn from the study due to conversion to on-pump surgery during the course of surgery. | Posted | Number | participants | 1month 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 | Tranexamic Acid Group | Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guyan Wang | Cardiovascular Institute & Fuwai Hospital | 86-10-88398377 | guyanwang2006@163.com |
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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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The placebo consisted of an equivalent volume of saline solution.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Postoperative Chest Tube Drainage | Posted | Mean | Standard Deviation | ml | 24h postoperative |
|
|
|
|
| 0 |
| 116 |
| 0 |
| 116 |
| EG001 | Control Group | The placebo consisted of an equivalent volume of saline solution. | 0 | 115 | 0 | 115 |
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