Comparison of Clinical efficacy and safety of injection of bovine thrombin and compression method in femoral pseudoaneurysm of patients undergoing PCI intervention at Rajaie Heart Center

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT138806112363N4

Enrollment

Registered

2010-09-23

Start date

2009-10-01

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Femoral pseudoaneurysm. Cardiac catheterization

Interventions

Intervention 1: Bovine thrombin, 100-700IU, percutaneous ultrasonographically guided injection, single dose or multiple doses, in 10-15 seconds. Intervention 2: Undergoing compression method in the si

Treatment - Drugs

Bovine thrombin, 100-700IU, percutaneous ultrasonographically guided injection, single dose or multiple doses, in 10-15 seconds

Undergoing compression method in the site of pseudoaneurysm in one or more than one episode, in about 30 minutes by an expert radiologist under sonography guide

Eligibility

Sex/Gender

All

Age

15 Years to 85 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age 15-85 years old, presence of vascular disease, presence of bleeding because of femoral pseudoaneurysm Exclusion criteria: pregnancy, breast feeding, past history of bleeding with thrombin

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Thrombosis time. Timepoint: At the time of treatment. Method of measurement: duplex sonography.;Pseudoaneurysm size. Timepoint: At the time of treatment. Method of measurement: duplex sonography.;Neck length and width. Timepoint: At the time of treatment. Method of measurement: duplex sonography.;Outcome of therapy. Timepoint: Baseline and 24 hours afterwards. Method of measurement: duplex sonography.;Complications. Timepoint: Baseline and 24 hours after wards. Method of measurement: duplex sonography.	—

Measure

Time frame

Thrombosis time. Timepoint: At the time of treatment. Method of measurement: duplex sonography.;Pseudoaneurysm size. Timepoint: At the time of treatment. Method of measurement: duplex sonography.;Neck length and width. Timepoint: At the time of treatment. Method of measurement: duplex sonography.;Outcome of therapy. Timepoint: Baseline and 24 hours afterwards. Method of measurement: duplex sonography.;Complications. Timepoint: Baseline and 24 hours after wards. Method of measurement: duplex sonography.

—

Secondary

Measure	Time frame
Coagulatory parameters. Timepoint: once before and after thrombin injection. Method of measurement: PT.PTT.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Nadermohammadi

Shahid Rajaie Heart Center

nadermohammadi.maryam@gmail.com+98 21 2209 2395

Outcome results

None listed

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