Effectiveness of different local haemostatic agents for bleeding control in carotid and femoral artery surgery

Topical application of tranexamic acid on vascular anastomoses - influence on postoperative drainage in comparison with other local haemostatics or no intervention

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN55441914

Enrollment

420

Registered

2025-03-31

Start date

2023-05-08

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Reduction of postoperative bleeding from vascular anastomoses after carotid and femoral artery surgery Surgery

Interventions

A total of 420 patients (calculated based on power analysis) will be included and divided into two main groups: one undergoing surgical treatment of the carotid artery and the other undergoing surgery

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 18 years of age and older 2. Surgical patients who underwent carotid endarterectomy 3. Surgical patients who underwent femoral artery reconstruction in the groin

Exclusion criteria

Exclusion criteria: Allergy to tranexamic acid

Design outcomes

Primary

Measure	Time frame
Effectiveness of haemostasis determined by the amount of blood (in ml) drained into the Redon drain over the course of the first 24 postoperative hours	—

Secondary

Measure	Time frame
1. Haematoma formation, assessed clinically from skin closure in the operating theatre to discharge 2. Postoperative wound infection (Surgical Site Infection [SSI]), the presence of infection assessed clinically (examination, wound secretion, temperature measurement, laboratory parameters, swab for microbiology culture) from the first postoperative day to discharge 3. Lymphorrhea: presence assessed clinically (examination, wound secretion) and by measuring and examining the Redon drainage content from the first postoperative day to discharge	—

Measure

Time frame

1. Haematoma formation, assessed clinically from skin closure in the operating theatre to discharge 2. Postoperative wound infection (Surgical Site Infection [SSI]), the presence of infection assessed clinically (examination, wound secretion, temperature measurement, laboratory parameters, swab for microbiology culture) from the first postoperative day to discharge 3. Lymphorrhea: presence assessed clinically (examination, wound secretion) and by measuring and examining the Redon drainage content from the first postoperative day to discharge

—

Countries

Croatia

Contacts

Public ContactAndrea Crkvenac Gregorek

acrkvena@kbc-zagreb.hr+ 385 (0)1 2367 782

Outcome results

None listed

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