Status:
COMPLETED
Does Tranexamic Acid Administration Reduce Blood Loss During Head and Neck Surgery?
Lead Sponsor:
Tata Memorial Hospital
Conditions:
Head and Neck Neoplasms
Eligibility:
All Genders
Phase:
PHASE3
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 type...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00147862
Start Date
May 1 2005
End Date
January 1 2007
Last Update
February 7 2007
Active Locations (1)
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1
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012