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

Phase 3
Not Enrolling
Head and Neck Neoplasms

Thank you

Trial Information

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

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Administration of tranexamic acid reduces perioperative blood loss and thus,

Principal Investigator

Atul P Kulkarni, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tata Memorial Hospital, Mumbai


India: Institutional Review Board

Study ID:




Start Date:

May 2005

Completion Date:

January 2007

Related Keywords:

  • Head and Neck Neoplasms
  • Tranexamic Acid
  • Antifibrinolytic Agents
  • Head and Neck Neoplasms
  • Thromboelastography
  • Neoplasms
  • Head and Neck Neoplasms