Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201705002182389 Date of Registration: 06/04/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison Between Streptokinase And Heparin Nebulizer In Patients with severe Acute Respiratory Distress Syndrome (ARDS)
Official scientific title Comparison Between Streptokinase And Heparin Nebulizer In Patients with Acute Respiratory Distress Syndrome (ARDS)
Brief summary describing the background and objectives of the trial The aim of this study to evaluate and compare the efficacy of using nebulized streptokinase, heparin in cases of ARDS in the intensive care unit assuming that the possible cause of non-responsiveness is the coagulation and fibrin formation in the collapsed alveoli.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) ARDS
Disease(s) or condition(s) being studied Acute Respiratory Distress Syndrome,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Comparison Between Streptokinase And Heparin Nebulizer
Anticipated trial start date 01/01/2017
Actual trial start date 01/01/2017
Anticipated date of last follow up 01/06/2017
Actual Last follow-up date 01/06/2017
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Recruiting
Publication URL NA
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group streptokinase nebulizer in ARDS 250000 iu / 4h 4 days nebulization 20
Experimental Group heparin nebulization in ARDS 10000 iu / 4 h 4 day nebulization 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Adult patients (21- 60 years) Admitted to the ICU with ARDS ¿ Patients with age less than 21 or more than 60 year ¿ Coagulopathy ¿ Heparin Induced Thrombocytopenia ¿ Previous administration of streptokinase ¿ Known or suspected allergy 21 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/02/2016 FM-BSU REC
Ethics Committee Address
Street address City Postal code Country
beni-suief beni-suief 082 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the average daily ratio of partial pressure of oxygen to FiO2 (PaO2/FiO2) ,lung compliance every 24h for a maximum 7 days from initiation
Secondary Outcome days free of mechanical ventilation , death , discharge daeth and discharge at day 28
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
beni- suief univerisity hospital beni-suief beni-suief 082 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
beni-suief univerisity beni-suief beni-suief 082 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Marwa khaled abd el-rhman beni-suief beni-suief 082 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr. Hatem EL moutaz Mahmoud cairo cairo 02 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marwa khaled dr.marwakhaled86@gmail.com 01220032700 beni-suief
City Postal code Country Position/Affiliation
beni-suief 082 Egypt assisstent lecturere
Role Name Email Phone Street address
Public Enquiries Marwa khaled dr.marwakhaled86@gmail.com 01220032700 beni-suief
City Postal code Country Position/Affiliation
beni-suief 082 Egypt assisstent lecturere
Role Name Email Phone Street address
Scientific Enquiries Marwa khaled dr.marwakhaled86@gmail.com 01220032700 beni suief
City Postal code Country Position/Affiliation
beni-suief 082 Egypt assisstent lecturere
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information