Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Herlev and Gentofte Hospital | OTHER |
| University Hospital Bispebjerg and Frederiksberg | OTHER |
| Hillerod Hospital, Denmark | OTHER |
| Copenhagen University Hospital, Hvidovre |
Not provided
Not provided
Not provided
Open label clinical randomized trial comparing three strategies for managing acute intermediate-high risk pulmonary embolism
Trial acronym: STRATIFY Background: Intermediate-high risk pulmonary embolism (PE) is associated with a significant risk of death or hemodynamic deterioration. The optimal treatment strategy should balance efficacy in reducing thrombus burden and hemodynamic compromise with risk of complications, in particular bleeding. Previous studies have investigated conventional high-dose, short term thrombolysis by (rtPA), finding a reduction in risk hemodynamic deterioration, but no reduction in mortality and a substantial increase in significant bleeding complications.
Catheter based techniques and low dose thrombolysis may offer lower risk of complication with reasonable efficacy. Such studies have not been performed in RCTs with a reasonable sample size, and no study have compared low dose intravenous thrombolysis and catheter based techniques.
The current trial addresses this paucity of data by randomizing patients to one of three treatment modalities:
Intervention: 1:1:1 randomization, stratified for site to
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| USAT + low dose thrombolysis | Active Comparator | UltraSound Assisted Thrombolysis (USAT) with low dose thrombolysis (20 mg of rtPA, Alteplase) over 6 hours plus unfractionated heparin (UFH) or low molecular weight heparin (LMWH) within 12 hours of randomization |
|
| Low dose thrombolysis | Active Comparator | Intravenous low dose thrombolysis (20 mg of rtPA, Alteplase) over 6 hours plus UFH or low molecular weight heparin (LMWH). |
|
| Heparin alone | No Intervention | UFH or low molecular weight heparin (LMWH) only (with option for conventional thrombolysis according to local protocols for hemodynamic deterioration) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alteplase 20 Mg Powder for Solution for Injection Vial | Drug | Low dose alteplase delivered IV or bu Ultrasound Assisted Thrombolysis device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Miller score comparing low dose thrombolysis and heparin alone groups | Reduction in Miller Score and on follow-up (48-96 h) CT pulmonary Angiography comparing low-dose rtPA (±USAT) to UFH/LMWH group (p<0.01, N=210) | at 48 to 96 hours post randomization |
| Reduction i Miller score comparing low dose thrombolysis by iv and by USATgroups | reduction in Miller Score and on follow-up (48-96 h) CT pulmonary Angiography comparing low-dose rtPA by USAT to iv, p<0.04, N=140) | at 48 to 96 hours post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of bleeding complications | Bleeding complications (major and minor bleeding complication according the TIMI classification) | Until hospital discharge, on average 1 week |
| Length of stay of index admission |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Altered mental state (GCS < 14)
No qualifying CT angiography performed (> 24 hour since CT angiography)
Females of child bearing potential, unless negative HCG test is present
Thrombolysis for PE within 14 days of randomization
Thrombus passing through patent Foramen Ovale (risk of paradoxical embolism)
Ongoing oral anticoagulation therapy (heparins, aspirin, antiplatelet therapy and NOAC allowed)
Comorbidity making 6 months survival unlikely
Absolute contraindications for thrombolysis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital Gentofte | Gentofte Municipality | Capital Region | 2900 | Denmark | ||
| Copenhagen University Hospital Bispebjerg Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41610160 | Derived | Kjaergaard J, Bang LE, Sonne-Holm E, Wiberg S, Holmvang L, Lassen JF, Sorensen R, Hofsten DE, Ulriksen PS, Jawad S, Palm P, Soe C, Ersboll MK, Boesgaard S, Moller JE, Thune JJ, Hassager C, Tilsted HH, Lonborg J, Egstrup M, Kristiansen OP, Seven E, Lindholm MG, Eskesen K, Fano S, Carlsen J. Randomized trial of low-dose, ultrasound-assisted thrombolysis or heparin for pulmonary embolism. Cardiovasc Res. 2026 Mar 26;122(4):539-549. doi: 10.1093/cvr/cvag038. | |
| 39732696 |
Not provided
Not provided
Main trial database
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
Randomized clinical trial with 1:1:1 allocation to treatment strata
Not provided
Not provided
Primary endpoint will be assessed by assessor blinded to the intervention
| Ultrasound assisted Thrombolysis | Device | Ultrasound assisted thrombolysis (USAT) |
|
Duration of index admission, including hospital based rehabilitation
| End of study, expected to be 5 years |
| Dyspnea index by visual analogue scale | Dyspnea index (Visual analog scale) after 48-96 h and after 3 months | End of study, expected to be 5 years |
| Change in oxygen supplement (FiO2) | FiO2 (in %) | at 48 to 96 hours post randomization |
| Mortality rate | Mortality in the three groups (log-rank), and hazard ratio in multivariable analysis using the UFH/LMWH as reference | End of study, expected to be 5 years |
| Incidence of Pulmonary Hypertension | Incidence of TR gradient > 40 mmHg at 3 months follow-up echocardiography | 3 months follow-up |
| 6 minute walk distance af follow-up | 6 minute walk distance at 3 months follow-up visit | 3 months follow-up |
| Health related Quality of Life (PEmb-QoL) | Health related Quality of Life at 3 months follow-up using PEmb-QoL (Pulmonary Embolism Quality of Life) ranging from 0 to 100, higher score indicating worse Quality of Life | 3 months follow-up |
| Health related Quality of Life (EQ-5D-5L) | 5Q-5D-5L (EuroQoL 5 dimension, 5 level questionnaire, ranging from -0.59 to 1, where 1 is the best possible health state) | 3 months follow-up |
| Bispebjerg |
| DK2400 |
| Denmark |
| Copenhagen University Hospital Rigshospitalet | Copenhagen | DK2100 | Denmark |
| Copenhagen University Hospital, Herlev Gentofte Hospital | Herlev | DK2730 | Denmark |
| Derived |
| Kjaergaard J, Carlsen J, Sonne-Holm E, Wiberg S, Holmvang L, Lassen JF, Sorensen R, Hofsten D, Ulriksen PS, Jawad S, Palm P, Thune JJ, Hassager C, Kristiansen OP, Eskesen K, Fano S, Bang LE. A randomized trial of low-dose thrombolysis, ultrasound-assisted thrombolysis, or heparin for intermediate-high risk pulmonary embolism-the STRATIFY trial: design and statistical analysis plan. Trials. 2024 Dec 28;25(1):853. doi: 10.1186/s13063-024-08688-4. |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D011208 | Powders |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided