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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.

A comparative study to evaluate the effect of two different doses of tranexamic acid in reducing intraoperative bleeding in patients undergoing pancreaticobiliary surgeries

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046692
Enrollment
62
Registered
2022-10-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: K80-K87- Disorders of gallbladder, biliary tract and pancreas

Interventions

Intervention1: tranexamic acid bolus followed by tranexamic acid infusion: 15 mg/kg tranexamic acid over 10 minutes will be given prior to surgical incision followed by tranexamic acid infusion of 1 m

Sponsors

All India Institute of Medical Sciences New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
to compare intraoperative blood loss between two groups( tranexamic acid bolus vs tranexamic acid bolus plus infusion)Timepoint: 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

MeasureTime frame
number of units of intraoperative PRBC transfused, percentage change in hematocrit( preoperative vs postoperative), duration of hospital stay, 28 days mortalityTimepoint: patients will be followed up 12 hrly for the first 24 hrs then daily during their hospital stay—

Countries

India

Contacts

Public ContactKelika Prakash

All India Institute of Medical Sciences

kelika.prakash@gmail.com9540947117

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026