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

This study has been completed.
Sponsor:
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00147862
First received: September 2, 2005
Last updated: February 6, 2007
Last verified: February 2007
  Purpose

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


Condition Intervention Phase
Head and Neck Neoplasms
Drug: Tranexamic Acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Does Tranexamic Acid Administration Reduce Blood Loss During Head and Neck Surgery?

Resource links provided by NLM:


Further study details as provided by Tata Memorial Hospital:

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

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

Estimated Enrollment: 240
Study Start Date: May 2005
Estimated Study Completion Date: January 2007
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00147862

Locations
India
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Atul P Kulkarni, MD Tata Memorial Hospital, Mumbai
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00147862     History of Changes
Other Study ID Numbers: TMH/185/IM-2004, TMH/185/IM-2004
Study First Received: September 2, 2005
Last Updated: February 6, 2007
Health Authority: India: Institutional Review Board

Keywords provided by Tata Memorial Hospital:
Tranexamic Acid
Antifibrinolytic Agents
Head and Neck Neoplasms
Thromboelastography

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Antifibrinolytic Agents
Tranexamic Acid
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014