The aim of this study is to compare thrombolytic therapy plus anticoagulant ,versus anticoagulant alone in patients with submassive pulmonary thromboemboli;Patients with acute pulmonary emboli who have ducumented pulmonary emboli in CT angiography with at least one of these criterias:1-Right ventricular dilatation and dysfunction or 2- Pulmonary artery hypertention in echocardiography , are enrolled in our study.Patients are excluded of study if they have : arterial hypotention; left heart or valvular disease ; and contraindication to anticoagulant or thrombolytic.
50 patients with sub massive pulmonary emboli who are admitted in Loghman Hakim hospital enrolled in this study sequentially.
Patients randomly assign to receive thrombolytic(Streptokinase 1500000unit or Alteplase 100mg/2 hours) plus Enoxaparine 1mg/kg/2 times a day for one week or only Enoxaparine 1mg/kg/2 times a day for one week.
The primary out come is in hospital death or clinical detoriation requiring an escalation of treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042017343N1
Registration date:2014-05-18, 1393/02/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-18, 1393/02/28
Registrant information
Name
Maryam Taherkhani
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Loghman Hakim Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 9005
Email address
m.taherkhani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Cardiovascular Reaserch Center , Shahid Beheshti University Of Medical Science
Expected recruitment start date
2011-04-04, 1390/01/15
Expected recruitment end date
2013-08-22, 1392/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Thrombolytic Therapy Plus Anticoagulant Versus Anticoagulant Alone In Sub Massive Pulmonary Thrombo Embolism: (A Randomized clinical trial )
Public title
Thrombolytic Therapy In Sub Massive Pulmonary Thromo Emboli
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients between 18 t0 80 years old ;pulmonary thrombo emboli in CT angiography ;right heart involvement in echocardiography;normal bood pressure
Exclusion criteria :patients under 18 ;patients under 80 ; normal echocardiography;left heart disease in echocardiography;arterial hypotention
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Heart Local Ethic Committee Of Loghman Hakim Hospital
Street address
Loghman Hakim Hospital, Makhsos street, South Kargar
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
1162
Health conditions studied
1
Description of health condition studied
Pulmonary Thrombo Emboli
ICD-10 code
I26.0
ICD-10 code description
Pulmonary embolism with mention of acute cor pulmonale
Primary outcomes
1
Description
in-hospital death
Timepoint
during hospitalization
Method of measurement
observation-
2
Description
clinical deterioration that required an escalation of treatment.
Timepoint
during hospitalization
Method of measurement
manometr-blood gas-pulse oximetry
Secondary outcomes
1
Description
Major Bleeding
Timepoint
During Hospitalization
Method of measurement
Hemoglobin Level
2
Description
Right Ventricular Size and Pulmonary Artery Pressure
Timepoint
At The Time Of Discharge
Method of measurement
Echo Cardiology
Intervention groups
1
Description
case group: Enoxaparin 1 milligram per kilogram 2 times a day for 7 days plus thrombolytic( Streptokinase 1500000 unit or Ateplase 100 milligram) in 2 hour
Category
Treatment - Drugs
2
Description
Control group: only Enoxaparine 1 milligram per killogram 2 times aday for one week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Dr Maryam Taherkhani
Street address
Makhsos Street, South Kargart
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
cardiovascular research center,Shahid Beheshti University Of Medical Sience
Full name of responsible person
Miss Vahedi
Street address
Cardiovascular Research Center, Saadat Abad Street, Kaj Squar
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
cardiovascular research center,Shahid Beheshti University Of Medical Sience
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Dr Maryam Taherkhani
Position
Assistant Professor Of Cardiology
Other areas of specialty/work
Street address
Loghman Hakim Hospital
City
Tehran
Postal code
Phone
+98 21 5541 9005
Fax
Email
m.taherkhani@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Dr Maryam Taherkhani
Position
Assistant Professor Of Cardiology
Other areas of specialty/work
Street address
Loghman Hakim Hospital, Makhsos Street, South Kargar
City
Ttehran
Postal code
Phone
+98 21 5541 9005
Fax
Email
m.taherkhani@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Dr Maryam Taherkhani
Position
Assistant Professor Of Cardiology
Other areas of specialty/work
Street address
Loghman Hakim Hospital , Makhsos Street, South Kargar
City
Tehran
Postal code
Phone
+98 21 5541 9005
Fax
Email
m.taherkhani@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)