Effect of tranexamic acid in patients undergoing pancreatoduodenectomy

Effect of tranexamic acid on blood loss during pancreatoduodenectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041190062

Enrollment

220

Registered

2019-08-15

Start date

2019-09-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing pancreatoduodenectomy for the disease of biliary tract, pancreas, and duodenum.

Interventions

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 fin

Tranexamic acid

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Intraoperative blood loss	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactYukihiro Yokoyama

Nagoya University Graduate School of Medicine

yyoko@med.nagoya-u.ac.jp+81-52-744-2222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026