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Intrapleural Urokinase for Retained Hemothorax (NTUH)

Primary Purpose

Retained Hemothorax

Status

Unknown status

Phase

Phase 3

Locations

Taiwan

Study Type

Interventional

Intervention

urokinase

placebo

About this trial

This is an interventional treatment trial for Retained Hemothorax focused on measuring non-surgical rate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Age: full 18 year-old

Exclusion Criteria:

Pregnancy
Active bleeding
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.
Cerebrovascular accident within 30 days
History of intracranial tumor or vascular abnormality
Have received thoracic surgery
Have received pleurodesis
Wish to receive thoracoscopic surgery for hematoma evacuation directly
Allergy to urokinase
Sepsis
Shock
People who are less than 18 years of age, prisoners, aborigines.

Sites / Locations

Chin-Chih Chang

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Urokinase

Control

Arm Description

arm of interest

Normal saline as a placebo for control arm

Outcomes

Primary Outcome Measures

non-surgical rate

Complete response and partial response

Secondary Outcome Measures

Full Information

NCT ID

NCT01134237

First Posted

May 27, 2010

Last Updated

May 28, 2010

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01134237

Brief Title

Intrapleural Urokinase for Retained Hemothorax

Acronym

NTUH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Unknown status

Study Start Date

May 2010 (undefined)

Primary Completion Date

August 2013 (Anticipated)

Study Completion Date

August 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retained Hemothorax

Keywords

non-surgical rate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Urokinase

Arm Type

Active Comparator

Arm Description

arm of interest

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Normal saline as a placebo for control arm

Intervention Type

Drug

Intervention Name(s)

urokinase

Intervention Description

intrapleural urokinase injection

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Normal saline as a placebo for control arm

Primary Outcome Measure Information:

Title

non-surgical rate

Description

Complete response and partial response

Time Frame

about 5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Age: full 18 year-old Exclusion Criteria: Pregnancy Active bleeding 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. Cerebrovascular accident within 30 days History of intracranial tumor or vascular abnormality Have received thoracic surgery Have received pleurodesis Wish to receive thoracoscopic surgery for hematoma evacuation directly Allergy to urokinase Sepsis Shock People who are less than 18 years of age, prisoners, aborigines.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chin-Chih Chang, MD

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chin-Chih Chang

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

12. IPD Sharing Statement

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Intrapleural Urokinase for Retained Hemothorax

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