A comparative study to evaluate the effect of two different doses (intravenously administered bolus vs iv bolus plus infusion) of tranexamic acid in reducing intraoperative blood loss in patients undergoing pancreaticobiliary surgeries.
- Conditions
- Disorders of gallbladder, biliary tract and pancreas,
- Registration Number
- CTRI/2022/10/046692
- Lead Sponsor
- All India Institute of Medical Sciences New Delhi
- Brief Summary
Intraoperative blood loss is a major concern in abdominal surgeries. It increases the incidence of blood transfusion which caries the risk of transfusion associated complications like infections, transfusion related acute lung injury , transfusion associated circulatory overload , acute hemolytic reaction and severe allergic reaction. Additionally increased increased intraoperative blood loss leads to administration of iv fluids which in turn leads to gut edema, ileus and anastomotic leaks. Tranexamic acid is an antifibrinolytic agent which is used intraoperatively to treat and prevent excessive blood loss. the dose of tranexamic acid required to reduce blood loss in patients undergoing trauma, orthopedic, cardiac and obstetrics is established. though tranexamic acid is routinely used during major abdominal surgeries there is wide variation in doses used in various studies. in addition not many studies have explored the effect of tranexamic acid on pancreaticobiliary surgeries. hence we designed this study to compare the effect of two different doses of tranexamic acid in reducing intraoperative blood loss in pancreaticobiliary surgeries.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 62
- ASA I and II patients undergoing open pancreaticobiliary surgeries( including surgeries for tumors, obstruction, injusries of the pancreas and bile ducts eg.
- Whipple surgery, pancreatectomy, extended cholecystectomy).
patients with known coagulopathy or thrombocytopenias, patients with history of stroke, , CAD or PVD , CKD or CLD, patients with history of DVT or thromboembolism, pregnant or lactating women, patients with preoperative Hb less than 10g/dl, patients undergoing major hepatic surgeries and patients having indwelling catheters( chemoports).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method to compare intraoperative blood loss between two groups( tranexamic acid bolus vs tranexamic acid bolus plus infusion) intraoperative blood loss will be assesed and patients will be followed up 12 hrly for the first 24 hrs then daily during their hospital stay
- Secondary Outcome Measures
Name Time Method number of units of intraoperative PRBC transfused, percentage change in hematocrit( preoperative vs postoperative), duration of hospital stay, 28 days mortality patients will be followed up 12 hrly for the first 24 hrs then daily during their hospital stay
Trial Locations
- Locations (1)
All India Institute of Medical Sciences, New Delhi
🇮🇳South, DELHI, India
All India Institute of Medical Sciences, New Delhi🇮🇳South, DELHI, IndiaDeeksha RajPrincipal investigator8940530324rajdeeksha343@gmail.com