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Intrapleural Urokinase for Retained Hemothorax (NTUH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01134237
Recruitment Status : Unknown
Verified May 2010 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 31, 2010
Last Update Posted : May 31, 2010
Sponsor:
Information provided by:
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE May 27, 2010
First Posted Date  ICMJE May 31, 2010
Last Update Posted Date May 31, 2010
Study Start Date  ICMJE May 2010
Estimated Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2010)		 non-surgical rate [ Time Frame: about 5 days ]
Complete response and partial response
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intrapleural Urokinase for Retained Hemothorax
Official Title  ICMJE Intrapleural Thrombolytic Treatment With Urokinase for Retained Hemothorax: A Prospective Double-blinded Randomized Multicenter Study
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Retained Hemothorax
Intervention  ICMJE
  • Drug: urokinase
    intrapleural urokinase injection
  • Drug: placebo
    Normal saline as a placebo for control arm
Study Arms  ICMJE
  • Active Comparator: Urokinase
    arm of interest
    Intervention: Drug: urokinase
  • Placebo Comparator: Control
    Normal saline as a placebo for control arm
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 28, 2010)		 32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2013
Estimated Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01134237
Other Study ID Numbers  ICMJE 200908047M
NTUH. 99-N1457 ( Other Grant/Funding Number: National Taiwan University Hospital )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Chin-Chih Chang, Department of Traumatology
Original Responsible Party Same as current
Current Study Sponsor  ICMJE National Taiwan University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chin-Chih Chang, MD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP