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
We studied efficacy and success rate of thrombin subcutaneous injection under ultrasound with compression method in the treatment of pseudoaneurysm and evaluated thrombin injection effects on coagulation parameters. 40 patients aged 15 to 85 years, after intervention with femoral pseudoaneurysm were randomly assigned into two groups to treat either under compression method or by subcutaneous injection under ultrasound thrombin. Thrombin vials were reconstituted with 0.9% normal saline in hospital pharmacy under laminar air flow. Pseudoaneurysm size, neck length and width, thrombin dose, thrombosis time, outcome of therapy and complications were recorded. Duplex sonography at 0 and 24 hours afterward were performed. Injection was stopped when no further flow was detected in pseudoaneurysm. Thromboplastin time and quick test (prothrombin time) were checked before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138806112363N4
Registration date:2010-09-23, 1389/07/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-09-23, 1389/07/01
Registrant information
Name
Fariborz Farsad
Name of organization / entity
Shahid Rajaie Heart Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2266 3310
Email address
farsad@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Rajaie Heart Center
Expected recruitment start date
2009-10-01, 1388/07/09
Expected recruitment end date
2010-05-01, 1389/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 15 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Rajaie Heart Center
Street address
Valiasr ave.
City
Tehran
Postal code
1996911151
Approval date
empty
Ethics committee reference number
6729
Health conditions studied
1
Description of health condition studied
Femoral pseudoaneurysm
ICD-10 code
Y84.0
ICD-10 code description
Cardiac catheterization
Primary outcomes
1
Description
Thrombosis time
Timepoint
At the time of treatment
Method of measurement
duplex sonography
2
Description
pseudoaneurysm size
Timepoint
At the time of treatment
Method of measurement
duplex sonography
3
Description
neck length and width
Timepoint
At the time of treatment
Method of measurement
duplex sonography
4
Description
outcome of therapy
Timepoint
Baseline and 24 hours afterwards
Method of measurement
duplex sonography
5
Description
complications
Timepoint
Baseline and 24 hours after wards
Method of measurement
duplex sonography
Secondary outcomes
1
Description
coagulatory parameters
Timepoint
once before and after thrombin injection
Method of measurement
PT.PTT
Intervention groups
1
Description
Bovine thrombin, 100-700IU, percutaneous ultrasonographically guided injection, single dose or multiple doses, in 10-15 seconds
Category
Treatment - Drugs
2
Description
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
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaie Heart Center
Full name of responsible person
Fariborz Farsad
Street address
Valiasr ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Rajaie Heart Center
Full name of responsible person
Fariborz Farsad
Street address
Valiasr ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Rajaie Heart Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Rajaie Heart Center
Full name of responsible person
Maryam Nadermohammadi
Position
pharmacy student
Other areas of specialty/work
Street address
Saadat abad street
City
Tehran
Postal code
Phone
+98 21 2209 2395
Fax
Email
nadermohammadi.maryam@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Rajaie Heart Center
Full name of responsible person
Fariborz Farsad
Position
clinical pharmacist/phd
Other areas of specialty/work
Street address
Valiasr ave.
City
Tehran
Postal code
Phone
+98 21663310
Fax
Email
farsad@rhc.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Rajaie Heart Center
Full name of responsible person
Maryam Nadermohammadi
Position
pharmacy student
Other areas of specialty/work
Street address
Saadat abad street
City
Tehran
Postal code
Phone
+98 21 2209 2395
Fax
Email
nadermohammadi.maryam@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)