Deep Vein Thrombosis, Postphlebitic Syndrome, Post Thrombotic Syndrome, Venous Thromboembolism, Venous Thrombosis
Conditions
Keywords
deep vein thrombosis, deep venous thrombosis, post thrombotic syndrome, blood clot, thrombolysis, tissue plasminogen activator, rt-PA, Activase, mechanical thrombectomy, pharmacomechanical, ATTRACT
Brief summary
The purpose of this study is to determine if the use of adjunctive Pharmacomechanical Catheter Directed Thrombolysis, which includes the intrathrombus administration of rt-PA--Activase (Alteplase),can prevent the post-thrombotic syndrome(PTS)in patients with symptomatic proximal deep vein thrombosis(DVT)as compared with optimal standard DVT therapy alone.
Detailed description
Activase, the study drug, is a fibrinolytic drug that is indicated for use in acute myocardial infarction, acute ischemic stroke, and acute massive pulmonary embolism in adults. Previous studies have established the ability of rt-PA to lyse venous thrombus in patients with deep vein thrombosis (DVT), and suggest that successful rt-PA mediated thrombolysis can prevent the post-thrombotic syndrome (PTS), a morbid, late complication of DVT that occurs in nearly 50% of patients. rt-PA is delivered directly into venous thrombus using a catheter/device which is embedded within the thrombus by a physician under imaging guidance. This method of rt-PA delivery, pharmacomechanical catheter-directed intrathrombus thrombolysis (PCDT),is thought to be safer, more effective, and more efficient than previous methods. The question of whether PCDT using rt-PA improves long-term DVT patient outcomes with acceptable risk and cost has not yet been addressed. The rationale for performing the ATTRACT Trial is based upon: * the major burden of PTS on DVT patients and the U.S. healthcare system * the association between rapid clot lysis and prevention of PTS * the proven ability of rt-PA to dissolve venous thrombus in proximal DVT * recent advances in CDT methods which may lower bleeding risk * the major clinical controversy on whether CDT should be routinely used for first-line DVT therapy
Interventions
Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.
Sponsors
McMaster University
Ontario Clinical Oncology Group (OCOG)
National Heart, Lung, and Blood Institute (NHLBI)
BSN Medical Inc
Genentech, Inc.
Medtronic - MITG
Boston Scientific Corporation
Mid America Heart Institute
Society of Interventional Radiology Foundation
Massachusetts General Hospital
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Symptomatic proximal DVT involving the iliac, common femoral, and/or femoral vein.
Exclusion criteria
* Age less than 16 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 iliac and/or common femoral vein; or b) for which thrombolysis is planned as part of the initial therapy. * Limb-threatening circulatory compromise. * Pulmonary embolism 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 glomerular filtration rate \[GFR\] \< 60 ml/min) or severe renal impairment in non-diabetic patients (estimated GFR \< 30 ml/min). * Active bleeding, recent (\< 3 mo) GI bleeding, severe liver dysfunction, bleeding diathesis. * Recent (\< 3 mo) internal eye surgery or hemorrhagic retinopathy; recent (\< 10 days) major surgery, cataract surgery, trauma, cardiopulmonary resuscitation, 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 \> 180 mmHg or diastolic \> 105 mmHg). * Pregnant (positive pregnancy test, women of childbearing potential must be tested). * Recently (\< 1 mo) had thrombolysis or is participating in another investigational drug study. * Use of a thienopyridine 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) | Between 6 and 24 months after randomization | Patients who experienced one of the following occurrences in the index leg between the 6 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Non-post-thrombotic Syndrome Treatment Failure | Through 24 months | A major non-post-thrombotic-syndrome treatment failure refers to when any of three events occurred in the index leg: 1) an unplanned endovascular procedure to treat severe venous symptoms within 6 months post-randomization; 2) venous gangrene within 6 months; or 3) an amputation within 24 months. |
| Moderate-to-severe Post-thrombotic Syndrome | Between 6 and 24 months after randomization | Proportion of patients with Villalta score of 10 or higher at any time between the 6 month and 24 month follow-up visits, inclusive. The Villalta scale ranges from 0-33 points, with higher scores being worse. |
| Major Bleeding | Within 10 days after randomization | Defined as clinically overt bleeding that is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal). |
| Any (Minor + Major) Bleeding | Within 10 days after randomization | Clinically overt bleeding that occurred through 10 days post-randomization |
| Any (Major + Minor) Bleeding | Within 24 months after randomization | Clinically overt bleeding that occurred within 24 months post-randomization |
| Recurrent Venous Thromboembolism | Within 10 days after randomization | Proportion of patients with symptomatic recurrent venous thromboembolism (including DVT and/or PE) |
| Death | Within 10 days after randomization | All-cause mortality |
| Any Treatment Failure | Through 24 months | Composite of PTS and major non-PTS treatment failure |
| Venous Clinical Severity Score | At 6 months | Mean Venous Clinical Severity Score (VCSS) at the specified follow-up visit; range 0-27 (did not use compression item), higher score is worse |
| Change in General Quality of Life - Physical | Baseline to 24 months post-randomization | Short-Form-36 Health Survey, Version 2, Physical Component Summary (PCS) Scale. Range of scores 0-100 with higher scores representing better quality of life. |
| Change in General Quality of Life - Mental | Baseline to 24 months post-randomization | Short-Form-36 Health Survey, Version 2, Mental Component Summary (MCS) Scale. Range of scores 0-100 with higher scores representing better quality of life. |
| Change in Venous Disease-specific Quality of Life | Baseline to 24 months post-randomization | Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) questionnaire. Range of scores 0-100 with higher scores representing better quality of life, and higher change scores representing greater improvement from baseline. |
| Change in Leg Pain Severity | Baseline to 10 days post-randomization | Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain |
| Change in Leg Circumference | Baseline to 10 days post-randomization | Mean calf circumference measured 10 cm below the tibial tuberosity |
| Severity of Post-thrombotic Syndrome (Villalta) | At 6 months | Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A-Intervention PCDT with intrathrombus delivery of rt-PA (maximum allowable total dose 35 mg) into the DVT over a period of up to 24 hours. Three methods of initial rt-PA delivery will be used: 1) Trellis-8 Peripheral Infusion System - maximum first-session rt-PA dose 25 mg; 2) AngioJet Rheolytic Thrombectomy System - maximum first-session rt-PA dose 25 mg; or 3) Catheter-directed rt-PA infusion for up to 24 hours at 0.01 mg/kg/hr (maximum 1.0 mg/hr) via a multisidehole infusion catheter. Before and after PCDT, patients will receive standard DVT therapy as in the Control Arm
Recombinant tissue plasminogen activator (rt-PA): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device. | 336 |
| B-Control Initial anticoagulant therapy with unfractionated heparin, enoxaparin, dalteparin, or tinzaparin, for at least 5 days, overlapped with long-term oral warfarin (target INR 2.0 - 3.0). Elastic compression stockings will be prescribed | 355 |
| Total | 691 |
Baseline characteristics
| Characteristic | Total | B-Control | A-Intervention |
|---|---|---|---|
| Age, Continuous | 53 years | 53 years | 52 years |
| Angina or myocardial infarction | 28 Participants | 15 Participants | 13 Participants |
| Aspirin use within past 7 days | 142 Participants | 74 Participants | 68 Participants |
| Asthma | 74 Participants | 38 Participants | 36 Participants |
| Body-mass index | 31 kilograms per square meter | 30 kilograms per square meter | 31 kilograms per square meter |
| Chronic obstructive pulmonary disease | 24 Participants | 15 Participants | 9 Participants |
| Congestive heart failure | 32 Participants | 19 Participants | 13 Participants |
| Diabetes | 113 Participants | 54 Participants | 59 Participants |
| DVT extends into iliac or common femoral vein | 391 Participants | 196 Participants | 195 Participants |
| DVT risk factors Childbirth | 8 Participants | 5 Participants | 3 Participants |
| DVT risk factors Hospitalization | 64 Participants | 38 Participants | 26 Participants |
| DVT risk factors Major surgery | 61 Participants | 34 Participants | 27 Participants |
| DVT risk factors None of the above risk factors | 541 Participants | 269 Participants | 272 Participants |
| DVT risk factors Plaster cast immobilization | 17 Participants | 9 Participants | 8 Participants |
| Estimated glomerular filtration rate | 86 milliliters per minute | 86 milliliters per minute | 86 milliliters per minute |
| Ethnicity (NIH/OMB) Hispanic or Latino | 41 Participants | 26 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 629 Participants | 319 Participants | 310 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 21 Participants | 10 Participants | 11 Participants |
| Height | 174 centimeters STANDARD_DEVIATION 11 | 174 centimeters STANDARD_DEVIATION 10 | 174 centimeters STANDARD_DEVIATION 11 |
| High cholesterol | 202 Participants | 105 Participants | 97 Participants |
| Hypertension | 282 Participants | 139 Participants | 143 Participants |
| Outpatient | 568 Participants | 300 Participants | 268 Participants |
| Previous DVT or PE | 170 Participants | 87 Participants | 83 Participants |
| Previous ipsilateral DVT | 19 Participants | 14 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 123 Participants | 62 Participants | 61 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 18 Participants | 10 Participants | 8 Participants |
| Race (NIH/OMB) White | 541 Participants | 276 Participants | 265 Participants |
| Sex: Female, Male Female | 265 Participants | 134 Participants | 131 Participants |
| Sex: Female, Male Male | 426 Participants | 221 Participants | 205 Participants |
| Side of index DVT Left leg | 425 Participants | 218 Participants | 207 Participants |
| Side of index DVT Right leg | 266 Participants | 137 Participants | 129 Participants |
| Symptom severity score Mild (5-9) | 239 Participants | 124 Participants | 115 Participants |
| Symptom severity score Moderate (10-14) | 192 Participants | 94 Participants | 98 Participants |
| Symptom severity score None or very mild (0-4) | 126 Participants | 69 Participants | 57 Participants |
| Symptom severity score Not documented | 2 Participants | 2 Participants | 0 Participants |
| Symptom severity score Severe (> 14) | 132 Participants | 66 Participants | 66 Participants |
| Time from symptom start to randomization | 6 days | 6 days | 6 days |
| Weight | 97 kilograms STANDARD_DEVIATION 24 | 96 kilograms STANDARD_DEVIATION 24 | 97 kilograms STANDARD_DEVIATION 25 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 336 | 8 / 355 |
| other Total, other adverse events | 0 / 336 | 0 / 355 |
| serious Total, serious adverse events | 109 / 336 | 86 / 355 |
Outcome results
Primary
Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)
Patients who experienced one of the following occurrences in the index leg between the 6 month and 24 month post-randomization follow-up visits, inclusive: 1) Villalta score of 5 or greater; 2) leg ulcer; or 3) late endovascular procedure performed to treat severe venous disease. The Villalta scale ranges from 0-33 points, with higher scores being worse.
Time frame: Between 6 and 24 months after randomization
Population: Modified full analysis set; intention-to-treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A-Intervention | Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) | 157 Participants |
| B-Control | Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) | 171 Participants |
p-value: 0.5695% CI: [0.82, 1.11]Cochran-Mantel-Haenszel
Secondary
Any (Major + Minor) Bleeding
Clinically overt bleeding that occurred within 24 months post-randomization
Time frame: Within 24 months after randomization
Population: Modified full analysis set, intention-to-treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A-Intervention | Any (Major + Minor) Bleeding | 46 Participants |
| B-Control | Any (Major + Minor) Bleeding | 38 Participants |
p-value: 0.2595% CI: [0.85, 1.89]Cochran-Mantel-Haenszel
Secondary
Any (Minor + Major) Bleeding
Clinically overt bleeding that occurred through 10 days post-randomization
Time frame: Within 10 days after randomization
Population: Modified full analysis set, intention-to-treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A-Intervention | Any (Minor + Major) Bleeding | 15 Participants |
| B-Control | Any (Minor + Major) Bleeding | 6 Participants |
p-value: 0.0395% CI: [1.04, 6.68]Cochran-Mantel-Haenszel
Secondary
Any Treatment Failure
Composite of PTS and major non-PTS treatment failure
Time frame: Through 24 months
Population: Modified full analysis set; intention to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A-Intervention | Any Treatment Failure | 158 Participants |
| B-Control | Any Treatment Failure | 176 Participants |
p-value: 0.3995% CI: [0.8, 1.09]Cochran-Mantel-Haenszel
Secondary
Change in General Quality of Life - Mental
Short-Form-36 Health Survey, Version 2, Mental Component Summary (MCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.
Time frame: Baseline to 24 months post-randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-Intervention | Change in General Quality of Life - Mental | 2.70 units on a scale | Standard Error 0.84 |
| B-Control | Change in General Quality of Life - Mental | 2.70 units on a scale | Standard Error 0.89 |
p-value: 0.99Regression, Linear
Secondary
Change in General Quality of Life - Physical
Short-Form-36 Health Survey, Version 2, Physical Component Summary (PCS) Scale. Range of scores 0-100 with higher scores representing better quality of life.
Time frame: Baseline to 24 months post-randomization
Population: Modified full analysis set; intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-Intervention | Change in General Quality of Life - Physical | 11.18 units on a scale | Standard Error 0.91 |
| B-Control | Change in General Quality of Life - Physical | 10.06 units on a scale | Standard Error 2.7 |
p-value: 0.37Regression, Linear
Secondary
Change in Leg Circumference
Mean calf circumference measured 10 cm below the tibial tuberosity
Time frame: Baseline to 30 days post-randomization
Population: Modified full analysis set; intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-Intervention | Change in Leg Circumference | -0.74 centimeters | Standard Error 0.17 |
| B-Control | Change in Leg Circumference | -0.28 centimeters | Standard Error 0.16 |
p-value: 0.05Regression, Linear
Secondary
Change in Leg Circumference
Mean calf circumference measured 10 cm below the tibial tuberosity
Time frame: Baseline to 10 days post-randomization
Population: Modified full analysis set; intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-Intervention | Change in Leg Circumference | -0.26 centimeters | Standard Error 0.17 |
| B-Control | Change in Leg Circumference | 0.27 centimeters | Standard Error 0.16 |
p-value: 0.02Regression, Linear
Secondary
Change in Leg Pain Severity
Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain
Time frame: Baseline to 30 days post-randomization
Population: Modified full analysis set; intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-Intervention | Change in Leg Pain Severity | -2.17 points | Standard Error 0.11 |
| B-Control | Change in Leg Pain Severity | -1.83 points | Standard Error 0.11 |
p-value: 0.03Regression, Linear
Secondary
Change in Leg Pain Severity
Likert pain scale ranging from 1-7, with higher scores representing a greater intensity of pain
Time frame: Baseline to 10 days post-randomization
Population: Modified full analysis set; intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-Intervention | Change in Leg Pain Severity | -1.62 points | Standard Error 0.1 |
| B-Control | Change in Leg Pain Severity | -1.29 points | Standard Error 0.1 |
p-value: 0.02Regression, Linear
Secondary
Change in Venous Disease-specific Quality of Life
Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) questionnaire. Range of scores 0-100 with higher scores representing better quality of life, and higher change scores representing greater improvement from baseline.
Time frame: Baseline to 24 months post-randomization
Population: Modified full analysis set; intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-Intervention | Change in Venous Disease-specific Quality of Life | 27.67 units on a scale | Standard Error 1.71 |
| B-Control | Change in Venous Disease-specific Quality of Life | 23.47 units on a scale | Standard Error 17.31 |
p-value: 0.08Regression, Linear
Secondary
Death
All-cause mortality
Time frame: Within 24 months after randomization
Population: Modified full analysis set; intention to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A-Intervention | Death | 7 Participants |
| B-Control | Death | 8 Participants |
p-value: 0.8395% CI: [0.33, 2.44]Cochran-Mantel-Haenszel
Secondary
Death
All-cause mortality
Time frame: Within 10 days after randomization
Population: Modified full analysis set; intention to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A-Intervention | Death | 0 Participants |
| B-Control | Death | 0 Participants |
Secondary
Major Bleeding
Defined as clinically overt bleeding that was associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).
Time frame: Within 24 months after randomization
Population: Modified full analysis set; intention-to-treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A-Intervention | Major Bleeding | 19 Participants |
| B-Control | Major Bleeding | 13 Participants |
p-value: 0.2395% CI: [0.76, 3.01]Cochran-Mantel-Haenszel
Secondary
Major Bleeding
Defined as clinically overt bleeding that is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g. intracranial, intraspinal).
Time frame: Within 10 days after randomization
Population: Modified full analysis set, intention-to-treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A-Intervention | Major Bleeding | 6 Participants |
| B-Control | Major Bleeding | 1 Participants |
p-value: 0.04995% CI: [0.78, 49.2]Cochran-Mantel-Haenszel
Secondary
Major Non-post-thrombotic Syndrome Treatment Failure
A major non-post-thrombotic-syndrome treatment failure refers to when any of three events occurred in the index leg: 1) an unplanned endovascular procedure to treat severe venous symptoms within 6 months post-randomization; 2) venous gangrene within 6 months; or 3) an amputation within 24 months.
Time frame: Through 24 months
Population: Modified full analysis set; intention to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A-Intervention | Major Non-post-thrombotic Syndrome Treatment Failure | 4 Participants |
| B-Control | Major Non-post-thrombotic Syndrome Treatment Failure | 7 Participants |
p-value: 0.3895% CI: [0.17, 1.98]Cochran-Mantel-Haenszel
Secondary
Moderate-to-severe Post-thrombotic Syndrome
Proportion of patients with Villalta score of 10 or higher at any time between the 6 month and 24 month follow-up visits, inclusive. The Villalta scale ranges from 0-33 points, with higher scores being worse.
Time frame: Between 6 and 24 months after randomization
Population: Modified full analysis set, intention-to-treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A-Intervention | Moderate-to-severe Post-thrombotic Syndrome | 60 Participants |
| B-Control | Moderate-to-severe Post-thrombotic Syndrome | 84 Participants |
p-value: 0.0495% CI: [0.54, 0.98]Cochran-Mantel-Haenszel
Secondary
Recurrent Venous Thromboembolism
Proportion of patients with symptomatic recurrent venous thromboembolism (including DVT and/or PE)
Time frame: Within 10 days after randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A-Intervention | Recurrent Venous Thromboembolism | 6 Participants |
| B-Control | Recurrent Venous Thromboembolism | 4 Participants |
p-value: 0.595% CI: [0.44, 5.28]Cochran-Mantel-Haenszel
Secondary
Recurrent Venous Thromboembolism
Symptomatic recurrent venous thromboembolism (DVT and/or PE)
Time frame: Within 24 months after randomization
Population: Modified full analysis set; intention to treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A-Intervention | Recurrent Venous Thromboembolism | 42 Participants |
| B-Control | Recurrent Venous Thromboembolism | 30 Participants |
p-value: 0.0995% CI: [0.94, 2.29]Cochran-Mantel-Haenszel
Secondary
Severity of Post-thrombotic Syndrome (Villalta)
Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Time frame: At 6 months
Population: Modified full analysis set; intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-Intervention | Severity of Post-thrombotic Syndrome (Villalta) | 3.11 points | Standard Error 0.24 |
| B-Control | Severity of Post-thrombotic Syndrome (Villalta) | 4.33 points | Standard Error 0.24 |
p-value: <0.001Regression, Linear
Secondary
Severity of Post-thrombotic Syndrome (Villalta)
Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Time frame: At 18 months
Population: Modified full analysis set; intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-Intervention | Severity of Post-thrombotic Syndrome (Villalta) | 3.32 points | Standard Error 0.24 |
| B-Control | Severity of Post-thrombotic Syndrome (Villalta) | 4.44 points | Standard Error 0.24 |
p-value: <0.001Regression, Linear
Secondary
Severity of Post-thrombotic Syndrome (Villalta)
Mean Villalta scale score at specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Time frame: At 24 months
Population: Modified full analysis set; intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-Intervention | Severity of Post-thrombotic Syndrome (Villalta) | 3.43 points | Standard Error 0.28 |
| B-Control | Severity of Post-thrombotic Syndrome (Villalta) | 4.50 points | Standard Error 0.29 |
p-value: 0.005Regression, Linear
Secondary
Severity of Post-thrombotic Syndrome (Villalta)
Mean Villalta scale score at the specified follow-up visit. Villalta score ranges from 0-33 points, with higher scores being worse.
Time frame: At 12 months
Population: Modified full analysis set; intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-Intervention | Severity of Post-thrombotic Syndrome (Villalta) | 3.22 points | Standard Error 0.22 |
| B-Control | Severity of Post-thrombotic Syndrome (Villalta) | 4.38 points | Standard Error 0.22 |
p-value: <0.001Regression, Linear
Secondary
Venous Clinical Severity Score
Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)
Time frame: At 12 months
Population: Modified full analysis set; intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-Intervention | Venous Clinical Severity Score | 1.80 points | Standard Error 0.16 |
| B-Control | Venous Clinical Severity Score | 2.37 points | Standard Error 0.16 |
p-value: 0.01Regression, Linear
Secondary
Venous Clinical Severity Score
Mean Venous Clinical Severity Score (VCSS) at the specified follow-up visit; range 0-27 (did not use compression item), higher score is worse
Time frame: At 6 months
Population: Modified full analysis set; intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-Intervention | Venous Clinical Severity Score | 1.73 points | Standard Error 0.15 |
| B-Control | Venous Clinical Severity Score | 2.68 points | Standard Error 0.15 |
p-value: <0.001Regression, Linear
Secondary
Venous Clinical Severity Score
Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)
Time frame: At 18 months
Population: Modified full analysis set; intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-Intervention | Venous Clinical Severity Score | 1.74 points | Standard Error 0.17 |
| B-Control | Venous Clinical Severity Score | 2.80 points | Standard Error 0.18 |
p-value: <0.001Regression, Linear
Secondary
Venous Clinical Severity Score
Mean VCSS score at the specified follow-up visit; range 0-27 (did not use compression item)
Time frame: At 24 months
Population: Modified full analysis set; intention to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-Intervention | Venous Clinical Severity Score | 1.87 points | Standard Error 0.18 |
| B-Control | Venous Clinical Severity Score | 2.42 points | Standard Error 0.19 |
p-value: 0.03Regression, Linear