Intrapleural Urokinase for Retained Hemothorax
Information source: National Taiwan University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Retained Hemothorax
Intervention: urokinase (Drug); placebo (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: National Taiwan University Hospital Official(s) and/or principal investigator(s): Chin-Chih Chang, MD, Principal Investigator, Affiliation: National Taiwan University Hospital
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.
Clinical Details
Official title: Intrapleural Thrombolytic Treatment With Urokinase for Retained Hemothorax: A Prospective Double-blinded Randomized Multicenter Study
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: non-surgical rate
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Chin-Chih Chang, Taipei 100, Taiwan
Additional Information
Starting date: May 2010
Last updated: May 28, 2010
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