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

NCT ID: NCT00147862

Last Updated: 2007-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2007-01-31

Brief Summary

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

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.

Conditions

Head and Neck Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Tranexamic Acid

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tata Memorial Hospital

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Atul P Kulkarni, MD

Role: PRINCIPAL_INVESTIGATOR

Tata Memorial Hospital, Mumbai

Locations

Tata Memorial Hospital

Mumbai, Maharashtra, India

Countries

India

Other Identifiers

TMH/185/IM-2004

Identifier Type: -

Identifier Source: secondary_id

TMH/185/IM-2004

Identifier Type: -

Identifier Source: org_study_id