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Tranexamic acid has been used in surgery for more than 30 years. It's effect on reducing bleeding and blood transfusing has been demonstrated.
In our hospital, the amount of cytorsductive surgery for ovarian cancer is big. During the perioperation , bleeding probability is high, and the supply of blood products is limited. In order to reduce bleeding, we're planning to use tranexamic acid in the operations.
In this experiment, we will observe the efficacy of tranexamic acid in cytoreductive surgery for ovarian cancer, find the best dosage which can reach the desired effect, and the possible side-effect.
We performed a single blind, prospective, randomised control trial (RCT) . The patients randomised assigned to three groups. Low dose TXA, high dose TXA or a placebo of IV saline which will be infused prior to skin incision in patients undergoing elective cytorsductive surgery for ovarian cancer .
Intraoperative blood loss will be estimated by the volume in the suction drains and by weighing the swabs. Postoperative blood loss will be estimated by the volume in the drains.
The other secondary outcomes will be inclued perioperation transfusion volume, thromboembolic complications, ICU length of stay (LOS), hospital LOS, adverse thrombogenic events within 30 days, 30-day all-cause readmission and so on.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high dose TXA | Experimental | TXA will be given as a 20mg/kg bolus followed by infusion of 5mg/ kg/hr per our anesthesia protocol |
|
| low dose TXA | Experimental | TXA will be given as a 10mg/kg bolus followed by infusion of 1mg/ kg/hr per our anesthesia protocol |
|
| normal saline | Placebo Comparator | saline will be given as a 4ml/kg bolus followed by infusion of 1ml/ kg/hr per our anesthesia protocolprotocol4ml/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Tranexamic Acid will be given through central vein |
|
| Measure | Description | Time Frame |
|---|---|---|
| operative and postoperative blood loss | the amount of bleeding | up to 8 days |
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Inclusion Criteria:
3) ASA I - II
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Zhang, PhD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Cancer Center, Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31865770 | Result | Zakhari A, Sanders AP, Solnik MJ. Tranexamic acid in gynecologic surgery. Curr Med Res Opin. 2020 Mar;36(3):513-520. doi: 10.1080/03007995.2019.1708533. Epub 2020 Jan 6. | |
| 26801659 | Result | Kietpeerakool C, Supoken A, Laopaiboon M, Lumbiganon P. Effectiveness of tranexamic acid in reducing blood loss during cytoreductive surgery for advanced ovarian cancer. Cochrane Database Syst Rev. 2016 Jan 23;2016(1):CD011732. doi: 10.1002/14651858.CD011732.pub2. |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| normal saline | Drug | normal saline will be given through central vein |
|
| 24428857 | Result | Lundin ES, Johansson T, Zachrisson H, Leandersson U, Backman F, Falknas L, Kjolhede P. Single-dose tranexamic acid in advanced ovarian cancer surgery reduces blood loss and transfusions: double-blind placebo-controlled randomized multicenter study. Acta Obstet Gynecol Scand. 2014 Apr;93(4):335-44. doi: 10.1111/aogs.12333. Epub 2014 Feb 25. |
| 32224739 | Result | Heyns M, Knight P, Steve AK, Yeung JK. A Single Preoperative Dose of Tranexamic Acid Reduces Perioperative Blood Loss: A Meta-analysis. Ann Surg. 2021 Jan 1;273(1):75-81. doi: 10.1097/SLA.0000000000003793. |
| 37029431 | Derived | Yang X, Chai M, Xia L, He Z, Wu X, Zhang J. Intraoperative use of tranexamic acid to reduce blood loss during cytoreductive surgery for advanced ovarian cancer: A randomized controlled clinical trial. Acta Obstet Gynecol Scand. 2023 Jul;102(7):950-959. doi: 10.1111/aogs.14567. Epub 2023 Apr 7. |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |