NTUH: Intrapleural Urokinase for Retained Hemothorax

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01134237
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Anticipated 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 1, 2010
• Anticipated Primary Completion Date: Aug 1, 2013
• Anticipated Study Completion Date: Aug 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. non-surgical rate [about 5 days]

   Complete response and partial response

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chin-Chih Chang	Taipei		Taiwan	100

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

• Principal Investigator: Chin-Chih Chang, MD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01134237
• Other Study ID Numbers: 200908047M; NTUH. 99-N1457
• First Posted: May 31, 2010
• Last Update Posted: May 31, 2010
• Last Verified: May 1, 2010

• Keywords provided by , ,: non-surgical rate
• Additional relevant MeSH terms: Hemothorax

Study Results

No Results Posted as of May 31, 2010