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.: PACTR201708002433467 Date of Approval: 16/07/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Early diagnosis and treatment of non-overt Disseminated Intravascular Coagulation in sepsis syndromes
Official scientific title Early diagnosis and treatment of non-overt disseminated intravascular coagulation (DIC) among sepsis syndrome patients: a randomized controlled study
Brief summary describing the background and objectives of the trial Disseminated intravascular coagulopathy (DIC) is the most dramatic example of derangement of the delicately balanced coagulation system. Critically ill children in the PICU may develop catastrophic thrombotic and hemorrhagic syndrome of DIC as a final common pathway complicating their underlying illness. The present study aimed at the evaluation of early laboratory diagnosis and early management of DIC in severe sepsis and septic shock patients admitted to the PICU, before the development of clinically overt DIC.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,DIC in children with severe sepsis and septic shock,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/01/2015
Actual trial start date 01/08/2015
Anticipated date of last follow up 31/12/2016
Actual Last follow-up date 31/01/2017
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Completed
Publication URL
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
Randomised Permuted block randomization (variable block size) Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Treated for DIC in the non-overt stage Fresh frozen plasma (IV) (15-20 ml /kg), Heparin (IV infusion) (5-10 U/kg/hr), Tranexamic acid (IV) (10-15 mg/kg) Until normalizing specific hematological lab. results group I as a combination of fresh frozen plasma (FFP) transfusion in a dose of 15-20 ml/kg, unfractionated heparin (5-10 U/Kg/hr) by continuous IV infusion, and antifibrinolytic agent (tranexamic acid) IV in a dose of 10-15 mg/kg. Group I was treated at the non-overt DIC stage 40
Experimental Group Treated for DIC if they developed overt DIC Fresh frozen plasma (IV) (15-20 ml /kg), Heparin (IV infusion) (5-10 U/kg/hr), Tranexamic acid (IV) (10-15 mg/kg) Until normalizing specific hematological lab. results group II was not treated except when they developed overt DIC. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients with severe sepsis or septic shock fulfilling the criteria according to the international guidelines. Patients with known bleeding disorders . Patients with leukemia 1 Month(s) 12 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 29/10/2015 IRB, Ethics Committee, Faculty of Medicine, Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Messalah, Alexandria, Egypt Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Development of overt DIC within 28 days of admission
Primary Outcome Shock reversal time within 28 days of admission
Primary Outcome Survival within 28 days of admission
Secondary Outcome Length of PICU stay Until discharge or deceased
Secondary Outcome Development of complications Until discharge or deceased
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria University Children Hospital Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Pediatric Departement, Faculty of Medicine, Alexandria University Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric Departement, Faculty of Medicine, Alexandria University Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Ibrahim Said 17 Champolion street, El Messalah Alexandria 21521 Egypt
Doaa Khater Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt
Hanan Fawzy Nazeer Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt
Ahmed Ahmed El nawawy Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt
Azza Ahmad Ahmad Moustafa Port Said St., El Shatby, Beside Bibliotheca of Alexandria Alexandria 21526 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed El Nawawy dr_anawawy@yahoo.com 002034837454 Port Said St., ElShatby, Beside Bibliotheca of Alexandria
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor of Pediatrics, Faculty of Medicine, University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 002-01223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Azza Moustafa profdrazzamoustafa@alexmed.edu.eg 00201008948826 Port Said St., ElShatby, Beside Bibliotheca of Alexandria
City Postal code Country Position/Affiliation
Alexandria 21526 Egypt Professor of Pediatrics, Head of PICU, Faculty of Medicine, University of Alexandria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information