Intrapleural Urokinase for Retained Hemothorax

Retained Hemothorax Clinical Trial

— NTUH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01134237
• Other study ID #: 200908047M
• Secondary ID: NTUH. 99-N1457
• Status: Active, not recruiting
• Phase: Phase 3
• First received: May 27, 2010
• Last updated: May 28, 2010
• Start date: May 2010
• Est. completion date: August 2013

Study information

• Verified date: May 2010
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemothorax
• Retained Hemothorax

Intervention

Drug:
• urokinase
intrapleural urokinase injection
• placebo
Normal saline as a placebo for control arm

Locations

Country	Name	City	State
Taiwan	Chin-Chih Chang	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	non-surgical rate	Complete response and partial response	about 5 days	Yes