Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147862
Status:
COMPLETED
Last Update Posted:
2007-02-07
First Post:
2005-09-02
Brief Title:
Does Tranexamic Acid Administration Reduce Blood Loss During Head and Neck Surgery
Sponsor:
Tata Memorial Hospital
Organization:
Tata Memorial Hospital
Study Overview
Official Title:
Does Tranexamic Acid Administration Reduce Blood Loss During Head and Neck Surgery
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Placeboinfusion 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
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 Placeboinfusion 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TMH185IM-2004 | None | None | None |