ClinicalTrials.gg
Status unknownNCT01134237NTUHUpdated May 31, 2010

Intrapleural Urokinase for Retained Hemothorax

A Phase 3 interventional study of urokinase and placebo in Retained Hemothorax, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-05-31.

Sponsored by National Taiwan University Hospital · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2010), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

We will recruit 32 patients in this study. The patients with retained hemothorax will be randomly divided into the urokinase group and the placebo group. In the urokinase group, urokinase 100,000 IU in 100 mL NaCl will be injected into the intrapleural space. We will record the daily drainage amount and evaluate the therapeutic effect by the chest X-ray. The therapeutic effect, safety, hospital stay, and medical cost between the two groups will be compared. This study will be done in four medical centers in northern Taiwan.

02

Conditions studied

  • Retained Hemothorax

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Keywords

  • non-surgical rate
03

In context

Hemothorax

26 studies on the registry are indexed under Hemothorax; 5 are open to participants now.

This study's planned enrollment of 32 is below the median of 100 across 21 interventional studies indexed under Hemothorax.

Browse Hemothorax studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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.
  2. Age: full 18 year-old

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy
  2. Active bleeding
  3. Coagulopathy, e.g. congenital or acquired coagulation abnormality, count less than 100,000 /μL, (INR) more than 1.5, or partial thromboplastin time, PTT, more than 50 seconds after treatment.
  4. Cerebrovascular accident within 30 days
  5. History of intracranial tumor or vascular abnormality
  6. Have received thoracic surgery
  7. Have received pleurodesis
  8. Wish to receive thoracoscopic surgery for hematoma evacuation directly
  9. Allergy to urokinase
  10. Sepsis
  11. Shock
  12. People who are less than 18 years of age, prisoners, aborigines.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
32 participants (estimated)

Study arms

  • Active comparator
    Urokinase

    arm of interest

    Drug: urokinase

  • Placebo comparator
    Control

    Normal saline as a placebo for control arm

    Drug: placebo

Interventions

  • intrapleural urokinase injection

  • Drugplacebo

    Normal saline as a placebo for control arm

06

What researchers measure

Primary outcomes

  1. non-surgical rate

    Complete response and partial response

    Time frame: about 5 days

07

Study locations

1 site
  • Chin-Chih Chang
    Taipei, 100, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01134237
First posted
May 31, 2010
Start date
May 2010
Primary completion
Aug 2013 (estimated)
Completion
Aug 2013 (estimated)
Last update
May 31, 2010

Study contacts

Chin-Chih Chang, MD
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Urokinase-Type Plasminogen Activator

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