This trial is active, not recruiting.

Condition retained hemothorax
Treatments urokinase, placebo
Phase phase 3
Sponsor National Taiwan University Hospital
Start date May 2010
End date August 2013
Trial size 32 participants
Trial identifier NCT01134237, 200908047M, NTUH. 99-N1457


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Active Comparator)
arm of interest
urokinase urokinase
intrapleural urokinase injection
(Placebo Comparator)
Normal saline as a placebo for control arm
placebo placebo
Normal saline as a placebo for control arm

Primary Outcomes

non-surgical rate
time frame: about 5 days

Eligibility Criteria

Male or female participants at least 18 years old.

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: 1. Pregnancy 2. Active bleeding 3. 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. 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.

Additional Information

Official title Intrapleural Thrombolytic Treatment With Urokinase for Retained Hemothorax: A Prospective Double-blinded Randomized Multicenter Study
Principal investigator Chin-Chih Chang, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by National Taiwan University Hospital.