Intrapleural Urokinase for Retained Hemothorax

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

Detailed Description
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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.

Official Title
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Intrapleural Thrombolytic Treatment With Urokinase for Retained Hemothorax: A Prospective Double-blinded Randomized Multicenter Study

Conditions
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Retained Hemothorax

Intervention / Treatment
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* Drug: urokinase
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Urokinase<br>arm of interest | Drug: urokinase<br>* intrapleural urokinase injection<br>|
| Placebo Comparator: Control<br>Normal saline as a placebo for control arm | Drug: placebo<br>* Normal saline as a placebo for control arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non-surgical rate | Complete response and partial response | about 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-surgical rate