Trial Outcomes & Findings for Low-Dose Alteplase to Treat Blood Clots in Deep Leg Veins (NCT NCT00082355)
NCT ID: NCT00082355
Last Updated: 2014-11-06
Results Overview
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.
COMPLETED
PHASE2
30 participants
6 months
2014-11-06
Participant Flow
Recruitment began in 2004 and was completed by 2009. All patients were treated at NIH Clinical Center.
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.
Participant milestones
| Measure |
Alteplase
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.
|
|---|---|
|
Initial Results of Thrombolytic Therapy
STARTED
|
30
|
|
Initial Results of Thrombolytic Therapy
COMPLETED
|
28
|
|
Initial Results of Thrombolytic Therapy
NOT COMPLETED
|
2
|
|
5 Year Recurrent Thromboembolism Rate
STARTED
|
28
|
|
5 Year Recurrent Thromboembolism Rate
COMPLETED
|
0
|
|
5 Year Recurrent Thromboembolism Rate
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Alteplase
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.
|
|---|---|
|
Initial Results of Thrombolytic Therapy
died of causes unrelated to protocol
|
1
|
|
Initial Results of Thrombolytic Therapy
Withdrawal by Subject
|
1
|
|
5 Year Recurrent Thromboembolism Rate
will be completed 2014
|
28
|
Baseline Characteristics
Low-Dose Alteplase to Treat Blood Clots in Deep Leg Veins
Baseline characteristics by cohort
| Measure |
Alteplase
n=30 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
46.7 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Alteplase
n=30 Participants
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.
|
|---|---|
|
Number of Participants With Restored Venous Function
|
28 participants
|
SECONDARY outcome
Timeframe: 5 daysPopulation: 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.
The outcome measures the number of participants who developed hemorrhage after receiving up to 4 days of Alteplase treatment for DVT.
Outcome measures
| Measure |
Alteplase
n=30 Participants
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.
|
|---|---|
|
Number of Participants That Developed Hemorrhage
|
0 participants
|
Adverse Events
Alteplase
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alteplase
n=30 participants at risk
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.
|
|---|---|
|
Vascular disorders
catheter insertion site hematoma
|
6.7%
2/30 • Number of events 2 • Data accumulated during 5 year study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place