NCT01134237

Brief Summary

Intrapleural thrombolytic treatment with urokinase for retained hemothorax is effective and safe. However, previous study was limited in prospective observation study without control group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 31, 2010

Status Verified

May 1, 2010

Enrollment Period

3.3 years

First QC Date

May 27, 2010

Last Update Submit

May 28, 2010

Conditions

Retained Hemothorax

Keywords

non-surgical rate

Outcome Measures

Primary Outcomes (1)

  • non-surgical rate

    Complete response and partial response

    about 5 days

Study Arms (2)

Urokinase

ACTIVE COMPARATOR

arm of interest

Drug: urokinase

Control

PLACEBO COMPARATOR

Normal saline as a placebo for control arm

Drug: placebo

Interventions

urokinaseDRUG

intrapleural urokinase injection

Urokinase
placeboDRUG

Normal saline as a placebo for control arm

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Retained hemothorax: it is defined as chest X-ray revealing obvious blood clot in pleural cavity after tube thoracostomy drainage for 3 days. The chest tubes are in good location and have no obstruction. The physician thinks the blood clot is difficult to drain.
  • Age: full 18 year-old

You may not qualify if:

  • Pregnancy
  • Active bleeding
  • Coagulopathy, e.g. congenital or acquired coagulation abnormality, platelet count less than 100,000 /μL, international normalized ratio (INR) more than 1.5, or partial thromboplastin time, PTT, more than 50 seconds after treatment.
  • Cerebrovascular accident within 30 days
  • History of intracranial tumor or vascular abnormality
  • Have received thoracic surgery
  • Have received pleurodesis
  • Wish to receive thoracoscopic surgery for hematoma evacuation directly
  • Allergy to urokinase
  • Sepsis
  • Shock
  • People who are less than 18 years of age, prisoners, aborigines.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chin-Chih Chang

Taipei, Taiwan, 100, Taiwan

Location

MeSH Terms

Interventions

Urokinase-Type Plasminogen Activator

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Chin-Chih Chang, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 27, 2010

First Posted

May 31, 2010

Study Start

May 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

May 31, 2010

Record last verified: 2010-05

Locations

TW(1)