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.: PACTR202004798675261 Date of Approval: 24/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of desmopressin on reducing blood loss in children with congenital cyanotic heart disease undergoing cardiopulmonary bypass
Official scientific title The effect of desmopressin on reducing blood loss in children with congenital cyanotic heart disease undergoing cardiopulmonary bypass
Brief summary describing the background and objectives of the trial Excessive bleeding and the needs for blood transfusions are common in patients undergoing cardiac surgery requiring cardiopulmonary bypass (CPB), and in some of these patients, there is a need for reoperation because of life‑threatening bleeding . Patients with cyanotic congenital heart disease (CCHD) have a significant tendency to bleed owing to the development of several coagulation abnormalities. These hemostasis abnormalities are attributed to thrombocytopenia, impaired platelet aggregation, overproduction of platelet microparticles, and shear stress due to blood hyperviscosity. This hemorrhagic diathesis is further accentuated by severe hemodilution in children because of the small blood volume compared to the CPB prime , platelet dysfunction, and loss of procoagulants during cardiopulmonary bypass (CPB) . Desmopressin or 1-deamino-8-D-arginine vasopressin (DDAVP) can increase the serum levels of von Willebrand factor (vWF) and coagulation factor VIII, so it can enhance platelet (PLT) function and improve coagulation. DDAVP has been used to treat many inherited bleeding diseases, and it also has been shown to be effective in treating some acquired bleeding disorders. Poor PLT function is one of the main causes for bleeding and allogeneic blood transfusion after cardiopulmonary bypass . The objective of this study is to evaluate the effect of DDAVP on blood loss as a primary outcome after surgery for CCHD requiring CPB. We also will investigate the rate RBCS transfusion, hours of mechanical ventilation, duration of intensive care unit, and hospital stay. The hypothesis is that, the use of DDAVP during pediatric cardiac surgery for cyanotic cardiac anomalies may decrease postoperative blood loss.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/04/2020
Actual trial start date 15/04/2020
Anticipated date of last follow up 01/06/2021
Actual Last follow-up date 24/06/2021
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants)
Recruitment status Recruiting
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group placebo control group Patients will receive normal saline 24 hours patients will receive a 20mL placebo over 30 minutes minutes after induction of anesthesia through a central venous catheter. This dose will be repeated every 6 hours for 24 hours. 26 Placebo
Experimental Group Desmopressin group 0.3 ug /kg in 20 mL of normal saline over 30minutes after induction of anesthesia through a central venous catheter. This dose will be repeated every 6 hours for 24 hours. 24 hours 0.3 ug /kg in 20 mL of normal saline over 30minutes after induction of anesthesia through a central venous catheter. This dose will be repeated every 6 hours for 24 hours. 26
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
This study will be conducted on a total of 52 patients with CCHD undergoing CPB of either sex with their age ranging from 3 to 72 month. Patients will be excluded from the current study in case of refusal of their guardians, redo cardiac surgery, pre existing coagulopathy, hepatic or renal dysfunction and history of allergy to desmopressin. Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s) 3 Month(s) 72 Month(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 15/03/2020 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 El-Gomhouria Street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the total amount of blood loss drained through mediastinal and pleural drainage tubes during the first 24 postoperative hours first 24 postoperative hours
Secondary Outcome rate RBCS transfusion, hours of mechanical ventilation, duration of intensive care unit, and hospital stay first postoperative 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university children hospital 2 El-Gomhouria Street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Ibrahim Abd Elbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university children hospital 2 El-Gomhouria Street Mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Ibrahim Abd Elbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
Nabil Abd El raouf Abd El mageed 2 El-Gomhouria Street Mansoura 35516 Egypt
Mohamed Maher El Morsy 2 El-Gomhouria Street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Abd Elbaser ibrahimbaser2010@yahoo.com +201004976825 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical Intensive Care at Mansoura University
Role Name Email Phone Street address
Public Enquiries Nabil Abd Elraouf nabil_abdelraouf@yahoo.com +201001538648 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Mohamed Maher El Morsy dr.sevo.anesthesia@gmail.com +201112582480 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical Intensive Care at Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will individual participate data and share it through the PubMed indexed journal Informed Consent Form,Study Protocol Form,Study Protocol Beginning 6 months and ending 12 months following article publication We will individual participate data and share it through the PubMed indexed journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://irb.mans.edu.eg No
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