NCT00147862

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

February 7, 2007

Status Verified

February 1, 2007

First QC Date

September 2, 2005

Last Update Submit

February 6, 2007

Conditions

Head and Neck Neoplasms

Keywords

Tranexamic AcidAntifibrinolytic AgentsHead and Neck NeoplasmsThromboelastography

Outcome Measures

Primary Outcomes (2)

  • Administration of tranexamic acid reduces perioperative blood loss and thus,

  • Requirement for replacement of blood in head and neck surgeries

Secondary Outcomes (2)

  • To observe procoagulant effects leading to complications, if any.

  • Cost effectiveness of the drug in terms of savings on blood transfusion requirements.

Interventions

Tranexamic AcidDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Atul P Kulkarni, MD

    Tata Memorial Hospital, Mumbai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

May 1, 2005

Study Completion

January 1, 2007

Last Updated

February 7, 2007

Record last verified: 2007-02

Locations

IN(1)