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

Primary Purpose

Head and Neck Neoplasms

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
Tata Memorial Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring Tranexamic Acid, Antifibrinolytic Agents, Head and Neck Neoplasms, Thromboelastography

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tata Memorial Hospital

Outcomes

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.

Full Information

First Posted
September 2, 2005
Last Updated
February 6, 2007
Sponsor
Tata Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00147862
Brief Title
Does Tranexamic Acid Administration Reduce Blood Loss During Head and Neck Surgery?
Official Title
Does Tranexamic Acid Administration Reduce Blood Loss During Head and Neck Surgery?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Tata Memorial Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
Keywords
Tranexamic Acid, Antifibrinolytic Agents, Head and Neck Neoplasms, Thromboelastography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
240 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Primary Outcome Measure Information:
Title
Administration of tranexamic acid reduces perioperative blood loss and thus,
Title
Requirement for replacement of blood in head and neck surgeries
Secondary Outcome Measure Information:
Title
To observe procoagulant effects leading to complications, if any.
Title
Cost effectiveness of the drug in terms of savings on blood transfusion requirements.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atul P Kulkarni, MD
Organizational Affiliation
Tata Memorial Hospital, Mumbai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tata Memorial Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India

12. IPD Sharing Statement

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

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