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Low-Dose Alteplase to Treat Blood Clots in Deep Leg Veins

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00082355
Recruitment Status : Completed
First Posted : May 6, 2004
Results First Posted : December 19, 2012
Last Update Posted : November 6, 2014
Sponsor:
Collaborator:
National Institutes of Health Clinical Center (CC)
Information provided by (Responsible Party):
Richard Chang, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Deep Venous Thrombosis of the Lower Extremity
Intervention Drug: Alteplase (Activase, Genentech)
Enrollment 30
Recruitment Details Recruitment began in 2004 and was completed by 2009. All patients were treated at NIH Clinical Center.
Pre-assignment Details 2 patients who were incorrectly diagnosed with Deep Vein Thrombosis (DVT) were excluded from the protocol after a preliminary ultrasound exam at NIH indicated they did not have DVT.
Arm/Group Title Alteplase
Hide Arm/Group Description Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
Period Title: Initial Results of Thrombolytic Therapy
Started 30
Completed 28
Not Completed 2
Reason Not Completed
died of causes unrelated to protocol             1
Withdrawal by Subject             1
Period Title: 5 Year Recurrent Thromboembolism Rate
Started 28
Completed 0 [1]
Not Completed 28
Reason Not Completed
will be completed 2014             28
[1]
data will not be complied until 2014
Arm/Group Title Alteplase
Hide Arm/Group Description Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
46.7  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
12
  40.0%
Male
18
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Number of Participants With Restored Venous Function
Hide Description The outcome measures the ability of Alteplase to lyse acute and subacute deep venous thrombosis (DVT) of the lower extremities and/or pelvis and restore venous function, or blood flow, to these areas. Restored venous function is also known as patency. Patency is measured by venography and ultrasound exams.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is an Intent-to-Treat (ITT) population. The initial goal was to be able to evaluate outcomes of treatment of DVT with alteplase over a 6 month period in 25 patients. 30 patients were treated but two participants did not complete the study before being assessed for this outcome measure.
Arm/Group Title Alteplase
Hide Arm/Group Description:
Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
28
2.Secondary Outcome
Title Number of Participants That Developed Hemorrhage
Hide Description The outcome measures the number of participants who developed hemorrhage after receiving up to 4 days of Alteplase treatment for DVT.
Time Frame 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is an Intent-to-Treat (ITT) population. The accrual target was to analyze outcomes(immediate, at 6 weeks, and at 6months) after treatment of DVT with alteplase in 25 patients. 30 patients were treated but two participants did not complete the study for 6 week and 6 month outcome assessments.
Arm/Group Title Alteplase
Hide Arm/Group Description:
Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
0
Time Frame Data accumulated during 5 year study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alteplase
Hide Arm/Group Description Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
All-Cause Mortality
Alteplase
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Alteplase
Affected / at Risk (%) # Events
Total   0/30 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alteplase
Affected / at Risk (%) # Events
Total   2/30 (6.67%)    
Vascular disorders   
catheter insertion site hematoma *  2/30 (6.67%)  2
*
Indicates events were collected by non-systematic assessment
Small trial of 30 patients does not have statistical power to prove clinical safety (expected to be <1 %)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Richard Chang
Organization: NIHCC
Phone: 301-402-0256
EMail: rchang@cc.nih.gov
Layout table for additonal information
Responsible Party: Richard Chang, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00082355    
Other Study ID Numbers: 040178
04-CC-0178 ( Other Identifier: NIH Clinical Center )
First Submitted: May 6, 2004
First Posted: May 6, 2004
Results First Submitted: February 8, 2011
Results First Posted: December 19, 2012
Last Update Posted: November 6, 2014