Status:
WITHDRAWN
Catheter-directed Thrombolysis Compared to Anticoagulation Alone for Acute Primary Iliofemoral Deep Venous Thrombosis
Lead Sponsor:
University of Toledo Health Science Campus
Conditions:
Deep Venous Thrombosis
Post Thrombotic Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Post-thrombotic syndrome (PTS) is a complication that can develop after deep vein thrombosis (DVT) of the lower extremities. PTS can occur at various times after the initial episode, but usually manif...
Detailed Description
Patients with Iliofemoral DVT are theoretically at the highest risk for development of PRS given involvement of the major drainage pathway of both superficial femoral and deep femoral veins. This woul...
Eligibility Criteria
Inclusion
- Age\>18 and younger than 75
- Symptomatic, proximal deep-vein thrombosis involving the Iliofemoral vein from 12/01/2019 to 12/01/2022
Exclusion
- Age less than 18 years or greater than 75 years.
- Symptom duration \> 14 days for the DVT episode in the index leg (i.e. non-acute DVT).
- In the index leg: established PTS, or previous symptomatic DVT within the last 2 years.
- In the contralateral (non-index) leg: symptomatic acute DVT a) involving the popliteal and/or tibial veins; or b) for which thrombolysis is planned as part of initial therapy.
- Limb-threatening circulatory compromise.
- PE with hemodynamic compromise (i.e. hypotension).
- Inability to tolerate PCDT procedure due to severe dyspnea or acute systemic illness.
- Allergy, hypersensitivity, or thrombocytopenia from heparin, rt-PA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
- Hemoglobin \< 9.0 mg/dl, INR \> 1.6 before warfarin was started, or platelets \< 100,000 /ml.
- Moderate renal impairment in diabetic patients (estimated GFR \< 60 ml/min) or severe renal impairment in non-diabetic patients (estimated GFR \< 30 ml/min).
- Active bleeding, recent (\< 3 months) GI bleeding, severe liver dysfunction, bleeding diathesis.
- Recent (\< 3 months) internal eye surgery or hemorrhagic retinopathy; recent (\< 10 days) major surgery, cataract surgery, trauma, CPR, obstetrical delivery, or other invasive procedure.
- History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
- Active cancer (metastatic, progressive, or treated within the last 6 months). Exception: patients with non-melanoma primary skin cancers are eligible to participate in the study.
- Severe hypertension on repeated readings (systolic \> 180mmHg or diastolic \> 105 mmHg).
- Pregnant (positive pregnancy test, women of childbearing potential must be tested).
- Recently (\< 2 years or chronic non-ambulatory status.
- Use of a thienopryridine antiplatelet drug (except clopidogrel) in the last 5 days.
- Life expectancy \< 2 years or chronic non-ambulatory status.
- Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance).
Key Trial Info
Start Date :
December 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04411316
Start Date
December 19 2019
End Date
December 19 2022
Last Update
September 9 2021
Active Locations (1)
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1
University of Toledo Medical Center
Toledo, Ohio, United States, 43614