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Does Tranexamic Acid Administration Reduce Blood Loss During Head and Neck Surgery?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00147862
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : February 7, 2007
Information provided by:
Tata Memorial Hospital

Brief Summary:
To Study whether infusion of Tranexamic Acid (a synthetic antifibrinolytic agent) reduces blood loss during head and neck surgery.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Drug: Tranexamic Acid Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Does Tranexamic Acid Administration Reduce Blood Loss During Head and Neck Surgery?
Study Start Date : May 2005
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Administration of tranexamic acid reduces perioperative blood loss and thus,
  2. Requirement for replacement of blood in head and neck surgeries

Secondary Outcome Measures :
  1. To observe procoagulant effects leading to complications, if any.
  2. Cost effectiveness of the drug in terms of savings on blood transfusion requirements.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All eligible previously untreated patients with resectable squamous cell carcinoma of the oral cavity
  • Undergoing composite resection of the mandible along with neck dissection and requiring reconstructive procedures in the form of pedicled flaps.
  • Patients who agree to participate by giving informed consent.

Exclusion Criteria:

  • Coagulopathy form any cause (Abnormal coagulogram - prothrombin time (PT) > 18 seconds or partial prothrombin time (PTT) > 50 seconds, recent (<5 days) acetylsalicylic acid ingestion, anticoagulant therapy (heparin, 4 hours preoperative or warfarin, 3 days preoperatively).
  • Pre-existing renal dysfunction (serum creatinine 200 mmol/L),
  • Known allergy to tranexamic acid,
  • Peripheral vascular disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00147862

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Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Sponsors and Collaborators
Tata Memorial Hospital
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Principal Investigator: Atul P Kulkarni, MD Tata Memorial Hospital, Mumbai
Layout table for additonal information Identifier: NCT00147862    
Other Study ID Numbers: TMH/185/IM-2004
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: February 7, 2007
Last Verified: February 2007
Keywords provided by Tata Memorial Hospital:
Tranexamic Acid
Antifibrinolytic Agents
Head and Neck Neoplasms
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action