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Intrapleural Urokinase for Retained Hemothorax

NCT ID: NCT01134237

Last Updated: 2010-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-08-31

Brief Summary

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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

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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.

Conditions

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Retained Hemothorax

Keywords

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non-surgical rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Urokinase

arm of interest

Group Type ACTIVE_COMPARATOR

urokinase

Intervention Type DRUG

intrapleural urokinase injection

Control

Normal saline as a placebo for control arm

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Normal saline as a placebo for control arm

Interventions

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urokinase

intrapleural urokinase injection

Intervention Type DRUG

placebo

Normal saline as a placebo for control arm

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Traumatology

Principal Investigators

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Chin-Chih Chang, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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Chin-Chih Chang

Taipei, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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NTUH. 99-N1457

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

200908047M

Identifier Type: -

Identifier Source: org_study_id