Does Tranexamic Acid Administration Reduce Blood Loss During Head and Neck Surgery?
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|ClinicalTrials.gov Identifier: NCT00147862|
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : February 7, 2007
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Neoplasms||Drug: Tranexamic Acid||Phase 3|
Blood and blood products are precious resources. Administration of blood and blood product carries with it the risk of postoperative bacterial infection1 and increased recurrence rates in certain types of cancers. Lower transfusion trigger, preoperative autologous blood donation with or without erythropoietin, intraoperative red blood cell salvage, regional anesthesia, controlled hypotension, and antifibrinolytic agents are all useful means to decrease the need for allogenic transfusions.
Tranexamic acid, a synthetic antifibrinolytic agent that binds to the lysine binding site of plasminogen and blocks the binding of plasminogen to the fibrin surface. Thus plasminogen activation is prevented and fibrinolysis is delayed. It has been used to reduce blood loss during coronary revascularization, orthotopic liver transplantation4, scoliosis correction surgery and other orthopedic procedures. The use of tranexamic acid intraoperatively has been shown to reduce blood loss by 25 - 40% in various studies. The primary concern when administering an antifibrinolytic drug is the potential increased incidence of thromboembolic events. A common misconception is that synthetic antifibrinolytic drugs increase blood clotting. The drugs do not alter blood clotting, but rather slow dissolution of blood clots. There is no data on the utility of tranexamic acid to reduce blood loss in head & neck cancer surgery.
We wanted to compare Tranexamic Acid infusion to Saline (Placebo)infusion to see whether Tranexamic ACid Administration will reduce blood loss. Reduction in transfusion requirements will lead to reduced costs and possible reduction in complications of blood transfusion.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Does Tranexamic Acid Administration Reduce Blood Loss During Head and Neck Surgery?|
|Study Start Date :||May 2005|
|Estimated Study Completion Date :||January 2007|
- Administration of tranexamic acid reduces perioperative blood loss and thus,
- Requirement for replacement of blood in head and neck surgeries
- To observe procoagulant effects leading to complications, if any.
- Cost effectiveness of the drug in terms of savings on blood transfusion requirements.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147862
|Tata Memorial Hospital|
|Mumbai, Maharashtra, India, 400012|
|Principal Investigator:||Atul P Kulkarni, MD||Tata Memorial Hospital, Mumbai|