Effect of tranexamic acid in patients undergoing pancreatoduodenectomy

JRCT ID: jRCTs041190062

Registered date:15/08/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients undergoing pancreatoduodenectomy for the disease of biliary tract, pancreas, and duodenum.
• Date of first enrollment: 27/09/2019
• Target sample size: 220
• Study type: Interventional

Intervention(s)

Arm tranexamic acid: Tranexamic acid (1g) plus normal saline (40mL) given over 10 minutes just before surgery and tranexamic acid (1g) plus normal saline (40mL) given over 8 hours or until surgery finish
Arm placebo: Normal saline (50mL) given over 10 minutes just before surgery and normal saline (50mL) given over 8 hours or until surgery finish

Outcome(s)

• Primary Outcome: Intraoperative blood loss
• Secondary Outcome: Amount of perioperative blood transfusion, anesthesia time, operation time, 28-day morbidity, postoperative anticoagulation therapy, postoperative laboratory variables (hemoglobin, platelet count, coagulation and fibrinolytic markers, white blood cells, C-reactive protein), length of hospital stay, in-hospital mortality, 90-day mortality, 3-year recurrence free survival/overall survival, 5-year recurrence free survival/overall survival, adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Age more or than 20 years, male and female.
2) Patients who will undergo open pancreatoduodenectomy (PD), including pylorus preserving PD, subtotal stomach preserving PD, and combined vascular resection, colon resection for the disease of biliary tract, pancreas, and duodenum. Hepatopancreatoduodenectomy and PD with other procedures are excluded.
3) Patients with written informed consent.

Exclude criteria

1) Absence of written informed consent.
2) Patients receiving thrombin therapy.
3) Patients using tranexamic acid within 7days before surgery.
4) Allergy to tranexamic acid.
5) Diagnosed protein C/S deficiency.
6) Past history of symptomatic deep venous thrombosis and/or pulmonary embolism.
7) Past history of cerebral infarction and/or myocardial infarction.
8) Patients with severe arteriosclerotic lesion under treatment
9) Past history of epilepsy
10) Patients with chronic kidney disease (serum creatinine more or than 2.8 mg/dL) or maintenance dialysis.
11) Participating other relevant interventional study.

Related Information

• Primary Sponsor: Yokoyama Yukihiro