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.: PACTR201901535105039 Date of Approval: 17/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Prospective study comparing between the effects of fibrinogen concentrate, and rFVIIa on reduction of blood products transfusion requirements in elective CABG
Official scientific title Prospective study comparing between the effects of fibrinogen concentrate, and recombinant activated factor VII on reduction of blood products transfusion requirements in elective coronary artery bypass surgery
Brief summary describing the background and objectives of the trial Excessive bleeding after cardiac surgery has been associated with increased morbidity and mortality related to transfusion- and hypoperfusion-related injuries to vital organ systems. Excessive bleeding after cardiac surgery has been related to a combination of several factors associated with cardiopulmonary bypass: activation of the coagulation cascade, fibrinolysis, and complement system. There are an increasing number of reports on off-label use of either recombinant activated factor VII (rVIIa), or fibrinogen concentrate for managing excessive bleeding after cardiac surgery. The aim of this study is to compare the effects of fibrinogen concentrate, and recombinant activated factor VII on reduction of blood products transfusion requirements in elective coronary artery bypass surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Haematological Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/11/2017
Actual trial start date 01/11/2017
Anticipated date of last follow up 30/09/2018
Actual Last follow-up date 30/09/2018
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
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group rFVIIa group recombinant activated factor VII at a dose of 45 ug/kg. Single dose Patients scheduled for CABG. Anesthetic technique, surgical technique and cardiopulmonary bypass management were standardized. following weaning from cardiopulmonary bypass, Heparin reversal was achieved through protamine sulphate administration at dose of 1.5 mg protamine per 100 IU heparin. Transfusion algorithms of blood products was be based on measurements of haemoglobin (Hb), thromboelastography to guide haemostatic intervention during intraoperative bleeding. • Packed RBC will be transfused, if HB < 8 g/dl during active bleeding. • 2 U of fresh-frozen plasma will be transfused, if R time > 20 mm. • 6 U of platelets will be transfused, if TEG MA < 45 mm. Patients with persistent clinical evidence of bleeding received recombinant activated factor VII at a dose of 45 ug/kg. 40
Control Group Fibrinogen group fibrinogen 25 mg/kg single dose Patients scheduled for CABG. Anesthetic technique, surgical technique and cardiopulmonary bypass management were standardized. following weaning from cardiopulmonary bypass, Heparin reversal was achieved through protamine sulphate administration at dose of 1.5 mg protamine per 100 IU heparin. Transfusion algorithms of blood products was be based on measurements of haemoglobin (Hb), thromboelastography to guide haemostatic intervention during intraoperative bleeding. • Packed RBC will be transfused, if HB < 8 g/dl during active bleeding. • 2 U of fresh-frozen plasma will be transfused, if R time > 20 mm. • 6 U of platelets will be transfused, if TEG MA < 45 mm. Patients with persistent clinical evidence of bleeding received fibrinogen 25 mg/kg. 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients scheduled coronary artery bypass grafting (CABG) persistent clinical evidence of bleeding, after heparin reversal, requiring hemostatic therapy, as assessed by anesthetist. Patients with previous cardiac surgery, patients with previous history of coagulopathy or thromboembolic manifestations. Patients with history of stroke. Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 70 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 08/10/2017 Research Ethics Committee faculty of medicine ain shams university FAW 000017585
Ethics Committee Address
Street address City Postal code Country
Abbasia, Cairo, Egypt. Cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Blood product transfusion requirement 24 hours after weaning from cardiopulmonary bypass
Secondary Outcome Thromboelastography parameters 24 hours after weaning from cardiopulmonary bypass
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams University Hospitals Abbasia Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Hospitals Abbasia, Cairo, Egypt Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Saleh Ahmed Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University Cairo Egypt
Sherine Kamal Zaki Kodeira Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University Cairo Egypt
Abdelkhalek Abdelmoneim Aboulseoud Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherine Kodeira sherinekodeira1@yahoo.com +201222127124 Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University
City Postal code Country Position/Affiliation
Cairo Egypt assistant professor of anesthesia
Role Name Email Phone Street address
Public Enquiries Moahmed Saleh drsalehm2002@hotmail.com +201227761463 Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries Mohamed Saleh drsalehm2002@hotmail.com +201227761463 Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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