NCT03595085

Brief Summary

Evaluating the safety and outcomes of catheter directed thrombolysis following catheter fragmentation in acute high risk pulmonary embolism

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

2.1 years

First QC Date

July 12, 2018

Last Update Submit

July 21, 2018

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    measure the estimates of deaths in the 30 days after pulmonary embolism diagnosis

    30 days

Secondary Outcomes (3)

  • Changes in blood pressure

    24 hours

  • oxygen saturation

    24 hours

  • changes in right ventricular dysfunction

    24 hours

Study Arms (2)

catheter directed interventions

EXPERIMENTAL

Those patients will undergo catheter directed fragmentation followed by local thrombolysis using streptokinase

Procedure: catheter directed fragmentation and thrombolysis

systemic thrombolysis

ACTIVE COMPARATOR

Those patients will receive systemic streptokinase

Drug: Streptokinase

Interventions

catheter directed fragmentation and thrombolysisPROCEDURE

A(6)F multipurpose catheter will be advanced over a guide wire under fluoroscopic guidance and used to measure right heart and pulmonary artery pressures, then mechanical catheter fragmentation will be done using a pigtail catheter. The catheter will be quickly spun manually so as to fragment the central thrombus and establish initial flow into pulmonary artery. After ensuring initial flow, Initial bolus dose of streptokinase (250.000 international unit) will be given over 10 min followed by continuous infusion of (100.000 international unit per hour)for 24 hours

catheter directed interventions
StreptokinaseDRUG

intravenous streptokinase at a dose of 250 000 international unit as a loading dose over 30 minutes, followed by 100 000 international unit per hour over 12-24 hours

systemic thrombolysis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with angiographically confirmed acute high risk pulmonary embolism with shock index \>1.
  • Pulmonary arterial occlusion with \>50% involvement of the central (main and/or lobar) pulmonary , and pulmonary hypertension (mean pulmonary artery pressure \>25 mmHg)
  • Patients with high risk pulmonary embolism who remain unstable after receiving fibrinolysis
  • Patients with high risk pulmonary embolism who cannot receive fibrinolysis
  • Patients with acute intermediate-high risk pulmonary embolism with adverse prognosis (new hemodynamic instability, worsening respiratory failure, severe RV dysfunction, or major myocardial necrosis)

You may not qualify if:

  • Patients with echocardiographically confirmed right sided thrombi.
  • Patients with low-risk pulmonary embolism or intermediater-low risk acute pulmonary embolism with minor RV dysfunction, minor myocardial necrosis, and no clinical worsening
  • Acute gastrointestinal bleeding.
  • Anticoagulation with international normalized ratio \>1.8 or severe coagulopathy.
  • Anaphylactic reaction to contrast media.
  • Acute stroke.
  • Acute renal failure or severe chronic non-dialysis dependent kidney disease.
  • Uncooperative patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Heit JA. The epidemiology of venous thromboembolism in the community. Arterioscler Thromb Vasc Biol. 2008 Mar;28(3):370-2. doi: 10.1161/ATVBAHA.108.162545. No abstract available.

    PMID: 18296591BACKGROUND

  • Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galie N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. No abstract available.

    PMID: 25173341BACKGROUND

  • Uflacker R. Interventional therapy for pulmonary embolism. J Vasc Interv Radiol. 2001 Feb;12(2):147-64. doi: 10.1016/s1051-0443(07)61821-1.

    PMID: 11265879BACKGROUND

  • Kasper W, Konstantinides S, Geibel A, Olschewski M, Heinrich F, Grosser KD, Rauber K, Iversen S, Redecker M, Kienast J. Management strategies and determinants of outcome in acute major pulmonary embolism: results of a multicenter registry. J Am Coll Cardiol. 1997 Nov 1;30(5):1165-71. doi: 10.1016/s0735-1097(97)00319-7.

    PMID: 9350909BACKGROUND

  • Stein PD, Alnas M, Beemath A, Patel NR. Outcome of pulmonary embolectomy. Am J Cardiol. 2007 Feb 1;99(3):421-3. doi: 10.1016/j.amjcard.2006.08.050. Epub 2006 Dec 15.

    PMID: 17261411BACKGROUND

  • Engelberger RP, Kucher N. Reperfusion Treatment for Acute Pulmonary Embolism. Hamostaseologie. 2018 May;38(2):98-105. doi: 10.1055/s-0038-1641717. Epub 2018 May 29.

    PMID: 29843174BACKGROUND

  • Kuo WT, Banerjee A, Kim PS, DeMarco FJ Jr, Levy JR, Facchini FR, Unver K, Bertini MJ, Sista AK, Hall MJ, Rosenberg JK, De Gregorio MA. Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT): Initial Results From a Prospective Multicenter Registry. Chest. 2015 Sep;148(3):667-673. doi: 10.1378/chest.15-0119.

    PMID: 25856269BACKGROUND

  • Mohan B, Chhabra ST, Aslam N, Wander GS, Sood NK, Verma S, Mehra AK, Sharma S. Mechanical breakdown and thrombolysis in subacute massive pulmonary embolism: A prospective trial. World J Cardiol. 2013 May 26;5(5):141-7. doi: 10.4330/wjc.v5.i5.141.

    PMID: 23710301BACKGROUND

  • Dilektasli AG, Demirdogen Cetinoglu E, Acet NA, Erdogan C, Ursavas A, Ozkaya G, Coskun F, Karadag M, Ege E. Catheter-Directed Therapy in Acute Pulmonary Embolism with Right Ventricular Dysfunction: A Promising Modality to Provide Early Hemodynamic Recovery. Med Sci Monit. 2016 Apr 15;22:1265-73. doi: 10.12659/msm.897617.

    PMID: 27081754BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Fibrinolytic AgentsStreptokinase

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fibrin Modulating AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesCardiovascular AgentsTherapeutic UsesHematologic AgentsEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 12, 2018

First Posted

July 23, 2018

Study Start

September 1, 2018

Primary Completion

October 1, 2020

Study Completion

March 1, 2021

Last Updated

July 24, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share