NCT04757129

Brief Summary

The investigators expect to enroll about 80-100 acute pulmonary embolism patients treated with thrombolysis in two hospitals. Dynamic changes of cardiopulmonary function after thrombolysis are detected to evaluate which indicators can quickly reflect the effectiveness of thrombolysis.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

4.5 years

First QC Date

January 29, 2021

Last Update Submit

May 9, 2024

Conditions

Acute Pulmonary Embolism

Keywords

acute pulmonary embolismthrombolysisAlteplasecardiopulmonary function

Outcome Measures

Primary Outcomes (1)

  • cardiopulmonary function changes

    changes of PO2，SBP，HR, cardiac ultrasound index and vasoactive drug dosage

    48 hours after thrombolysis

Study Arms (2)

thrombolysis success group

Echocardiography was performed 48 hours after thrombolysis to evaluate the success of thrombolysis according to previous report.

thrombolysis failure group

Echocardiography was performed 48 hours after thrombolysis to evaluate the success of thrombolysis according to previous report.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

medium-high risk or high risk pulmonary embolism and treated with thrombolysis

You may qualify if:

  • medium-high risk or high risk pulmonary embolism and treated with thrombolysis

You may not qualify if:

  • lack of radiologic evidence to diagnose APE
  • death within 48 hours after thrombolytic therapy
  • unable to partner treatment and leaving hospitals
  • missing other necessary data
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Central Study Contacts

Bin He, Master

CONTACT

13770789159hbhbwywy34@sina.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending physician of Affiliated Hospital of Nanjing Medical University

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 17, 2021

Study Start

January 1, 2020

Primary Completion

June 30, 2024

Study Completion

September 30, 2024

Last Updated

May 13, 2024

Record last verified: 2024-05

Locations

CN(1)