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Intrapleural Urokinase for Retained Hemothorax (NTUH)

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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

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.

Condition or disease Intervention/treatment Phase
Retained Hemothorax Drug: urokinase Drug: placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Intrapleural Thrombolytic Treatment With Urokinase for Retained Hemothorax: A Prospective Double-blinded Randomized Multicenter Study
Study Start Date : May 2010
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Urokinase

Arm Intervention/treatment
Active Comparator: Urokinase
arm of interest
Drug: urokinase
intrapleural urokinase injection

Placebo Comparator: Control
Normal saline as a placebo for control arm
Drug: placebo
Normal saline as a placebo for control arm




Primary Outcome Measures :
  1. non-surgical rate [ Time Frame: about 5 days ]
    Complete response and partial response



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134237


Locations
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Taiwan
Chin-Chih Chang
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Chin-Chih Chang, MD National Taiwan University Hospital
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Responsible Party: Chin-Chih Chang, Department of Traumatology
ClinicalTrials.gov Identifier: NCT01134237    
Other Study ID Numbers: 200908047M
NTUH. 99-N1457 ( Other Grant/Funding Number: National Taiwan University Hospital )
First Posted: May 31, 2010    Key Record Dates
Last Update Posted: May 31, 2010
Last Verified: May 2010
Keywords provided by National Taiwan University Hospital:
non-surgical rate
Additional relevant MeSH terms:
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Hemothorax
Pleural Diseases
Respiratory Tract Diseases
Hemorrhage
Pathologic Processes