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

Head and Neck Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147862
• Other study ID #: TMH/185/IM-2004
• Secondary ID: TMH/185/IM-2004
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: February 6, 2007
• Start date: May 2005
• Est. completion date: January 2007

Study information

• Verified date: February 2007
• Source: Tata Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Drug:
• Tranexamic Acid

Locations

Country	Name	City	State
India	Tata Memorial Hospital	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Administration of tranexamic acid reduces perioperative blood loss and thus,
Primary	Requirement for replacement of blood in head and neck surgeries
Secondary	To observe procoagulant effects leading to complications, if any.
Secondary	Cost effectiveness of the drug in terms of savings on blood transfusion requirements.