Head and Neck NeoplasmsPhase 3NCT00147862
Does Tranexamic Acid Administration Reduce Blood Loss During Head and Neck Surgery?
A Phase 3 study testing Tranexamic Acid in people with Head and Neck Neoplasms, run by Tata Memorial Hospital at 1 site in India.
Trial summary
To Study whether infusion of Tranexamic Acid (a synthetic antifibrinolytic agent) reduces blood loss during head and neck surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Tranexamic Acid
- How many people
- 240 participants
- Where
- 1 siteIndia
- Study dates
- May 2005to Jan 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To Study whether infusion of Tranexamic Acid (a synthetic antifibrinolytic agent) reduces blood loss during head and neck surgery.
Read the 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
- Being tested
- Tranexamic Acid
- Keywords
- Tranexamic Acid, Antifibrinolytic Agents, Head and Neck Neoplasms, Thromboelastography
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startMay 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Investigators
- Atul P Kulkarni, MD, Principal investigator, Tata Memorial Hospital, Mumbai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147862
- Sponsor's protocol ID
- TMH/185/IM-2004
- Other IDs
- TMH/185/IM-2004
- Status last verified
- Feb 2007
- First submitted
- 2 Sep 2005
- Last updated
- 7 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Tranexamic Acid Administration Reduce Blood Loss During Head and Neck Surgery?
- ClinicalTrials.gov ID
- NCT00147862
- Acronym / sponsor ID
- TMH/185/IM-2004
- Conditions
- Head and Neck Neoplasms
- Keywords
- Tranexamic Acid, Antifibrinolytic Agents, Head and Neck Neoplasms, Thromboelastography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- May 2005
- Study completion
- Jan 2007
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid | Drug | – |
Primary outcome
Administration of tranexamic acid reduces perioperative blood loss and thus,
Requirement for replacement of blood in head and neck surgeries
2 secondary outcomes
To observe procoagulant effects leading to complications, if any.
Cost effectiveness of the drug in terms of savings on blood transfusion requirements.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atul P Kulkarni, MD principal investigator
Tata Memorial Hospital, Mumbai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic Acid in people with Head and Neck Neoplasms, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Administration of tranexamic acid reduces perioperative blood loss and thus,. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2007.