|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01134237 |
|
Date of registration:
|
27/05/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Intrapleural Urokinase for Retained Hemothorax
NTUH |
|
Scientific title:
|
Intrapleural Thrombolytic Treatment With Urokinase for Retained Hemothorax: A Prospective Double-blinded Randomized Multicenter Study |
|
Date of first enrolment:
|
May 2010 |
|
Target sample size:
|
32 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01134237 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Taiwan
| | | | | | | |
|
Contacts
|
|
Name:
|
Chin-Chih Chang, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
National Taiwan University Hospital |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Retained Hemothorax
|
|
Intervention(s)
|
|
Drug: placebo
|
|
Drug: urokinase
|
|
Primary Outcome(s)
|
|
non-surgical rate
[Time Frame: about 5 days]
|
|
Secondary ID(s)
|
|
200908047M
|
|
NTUH. 99-N1457
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|