Effects of intravenous and catheter directed thrombolytic therapy with recombinant tissue plasminogen activator (Alteplase) in non-traumatic acute limb ischemia; a randomized double-blind clinical trial
The aim of the current study is to evaluate the efficacy of systemic and catheter directed thrombolysis by alteplase in the patients with acute limb ischemia (ALI). We will include 40 patients who are less than 75 years, symptoms duration of 1 to 14 days, ALI of grade IIa and IIb and absence of distal run off. Those with absolute and relative contraindications of thrombolytic therapy will be excluded. Patients will randomly assign to undergo intravenous (0.6 mg per kg over 2 hours) or catheter directed thrombolysis (0.05 mg per kg per hr each 2 hours for 24 hours) with alteplase. The primary endpoint of the study is improvement of clinical status according to Rutherford classification, improvement in pain according to VAS score and improvement in ABI which would be assessed at 1 week, 3, 6 and 12 months after intervention. The secondary endpoint of the study is complete or near complete recanalization of the occluded artery detected by angiography after 1 year of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014100719427N1
Registration date:2015-07-07, 1394/04/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-07, 1394/04/16
Registrant information
Name
Hassan Ravari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5311
Email address
lotfiane1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research, Mashhad University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of intravenous and catheter directed thrombolytic therapy with recombinant tissue plasminogen activator (Alteplase) in non-traumatic acute limb ischemia; a randomized double-blind clinical trial
Public title
Intravenous versus catheter directed thrombolytic therapy in non-traumatic acute limb ischemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 18 to 75 years; symptoms duration of 1 to 14 days; Acute limb ischemia (ALI) of grade IIa and IIb according to the Rutherford classification; absence of distal run off in angiography; Ankle-Brachial Index (ABI) less than 0.8
Exclusion criteria: Severe anemia (Hb less than 8 gr per dL); thrombocytopenia (platelet count less than 80000 per micl); low serum fibrinogen (fibrinogen less than 100 mg per dL); severe hypertension (systolic more than 160 mmHg, diastolic more than 100 mmHg); trauma or surgery less than 14 days before intervention; history of subarachnoid hemorrhage; life expectancy of less than 14 months; major internal bleeding less than 6 months before intervention; pregnancy; lumbar puncture 2 weeks before intervention
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
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
Computer-based random digit generator using the admission numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
University street
City
Mashahd
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
89-5511
Health conditions studied
1
Description of health condition studied
Obliteration of lower extremity arteries
ICD-10 code
I79.8
ICD-10 code description
Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere
Primary outcomes
1
Description
Clinical condition
Timepoint
1 week, 1, 3, 6, 12 months
Method of measurement
Rutherford classification; Pain severity measured by VAS; ABI
Secondary outcomes
1
Description
Complete or near complete recanalization of the occluded artery
Timepoint
12 months
Method of measurement
Angiography
Intervention groups
1
Description
Group 1: Alteplase 0.6 mg per kg intravenously in 2 hours. Half of the dosage would be given as bolus dose and the rest would be infused in 2 hours.
Category
Treatment - Drugs
2
Description
Group 2: Alteplase infusion via catheter directed route with 0.05 mg per kg per hour each 2 hours for 24 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Hossein Ravari
Street address
Imam Reza square, Ebne Sina street
City
Mashahd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
University street
City
Mashahd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research, Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Ravari
Position
Associate Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Ebne Sina Street
City
Mashhad
Postal code
Phone
+98 51 3852 5311
Fax
Email
ravarih@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Ravari
Position
Vascular Surgeon
Other areas of specialty/work
Street address
Imam Reza Hospital, Ebne Sina street
City
Mashhad
Postal code
Phone
+98 51 3852 5311
Fax
Email
mvasrc@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hassan Ravari
Position
Associate Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Ebne Sina Street
City
Mashhad
Postal code
Phone
+98 51338543031
Fax
Email
mvasrc@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)