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.: PACTR202402769956111 Date of Approval: 06/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Rotational Thromboelastometry Guided Transfusion Protocol versus Classical Transfusion Protocol in Reducing Blood Components Transfusion in Adult Patients Undergoing Elective Cardiac Surgery
Official scientific title Rotational Thromboelastometry Guided Transfusion Protocol versus Classical Transfusion Protocol in Reducing Blood Components Transfusion in Adult Patients Undergoing Elective Cardiac Surgery: A Randomized Clinical Trial
Brief summary describing the background and objectives of the trial Severe bleeding is a common complication of cardiac surgeries, especially those that use cardiopulmonary bypass. The amount of bleeding during surgery can range from minimal to excessive, which may affect up to 11% of patients. Cardiac surgeries can also cause coagulation problems, which have various causes. These include platelet dysfunction, hemodilution, coagulation factor deficiency, fibrinolytic system activation, and residual heparin or protamine overdose. Excessive bleeding after surgery requires prompt treatment with allogenic blood transfusion, pharmacological hemostatic agents, or thoracic re-exploration if needed. However, these interventions can worsen the clinical outcome of the patients. Activated clotting time (ACT) is often used to monitor and adjust heparin or protamine dosage during and after cardiopulmonary bypass (CPB). However, ACT values depend not only on heparin concentration, but also on hemodilution, low platelet count, low fibrinogen, and excess protamine. Rotational thromboelastometry device can detect coagulation inhibitors such as heparin in intrinsic activation plus heparinase neutralization (HEPTEM test) and can be used to identify the presence of heparin and its effect on coagulation by comparison with intrinsically activated measurement containing no heparinase (INTEM). Our study aimed to assess the efficacy of ROTEM guided transfusion protocol on reducing the need for blood components transfusion in patients scheduled for cardiac surgeries with CPB.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/10/2019
Actual trial start date 01/10/2019
Anticipated date of last follow up 31/07/2022
Actual Last follow-up date 31/07/2022
Anticipated target sample size (number of participants) 32
Actual target sample size (number of participants)
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
Control Group Classical transfusion protocol First 24 hours postoperatively 1. After induction of anesthesia, baseline blood samples will be withdrawn for ACT, PT, aPTT &INR and CBC. 2. Blood samples for platelets function will be taken after induction of anesthesia from patients who received antiplatelet therapy. Measurement time is 6 minutes and results expressed in three parameters, amplitude at 6 min Ohm (A6), maximum slope Ohm/min (MS), and area under curve Ohm/min (AUC). 3. Blood sample will be taken after protamine administration by 5 minutes (protamine+5) for ACT, all laboratory tests (CBC, PT, INR, aPTT). 4. Patients with prolonged ACT will have another blood sample for ACT withdrawn after classic management to assess adequate heparin reversal (Prolonged ACT will be defined as increase more than 10 % from baseline). 16 Active-Treatment of Control Group
Experimental Group ROTEM guided transfusion protocol 24 hours postoperatively. 1. After induction of anesthesia, blood samples will be withdrawn for baseline hemostatic measurement (baseline ACT, baseline PT, aPTT, INR, and CBC). 2. Blood samples for platelets function will be taken after induction of anesthesia from patients who received antiplatelets therapy. Measurement time is 6 minutes and results expressed in three parameters, amplitude at 6 min Ohm (A6), maximum slope Ohm/min (MS), and area under curve Ohm/min (AUC). 3. Rotational thrombelastometry (ROTEM, Pentapharm GmbH,Munich,Germany) assay will be taken after induction of anesthesia, at rewarming and 5 minutes after protamine administration. Tests include: • Extrinsically activated coagulation test (EXTEM). • Fibrin polymerization test (FIBTEM). • Intrinsically activated coagulation test (INTEM). • Intrinsically activated coagulation without heparin (HEPTEM). 4. Clot formation will be assessed by clotting time (CT), clot formation time (CFT), maximum clot firmness (MCF), amplitude after 10 min (A10) and hyperfibrinolysis after 30 minutes (Ly30). 5. EXTEM/FIBTEM will be done at rewarming at the end of cardiopulmonary bypass to guide ordering platelet, fresh frozen plasma or cryoprecipitate if indicated. 6. Blood sample will be taken after protamine administration by 5 minutes (protamine+5) all ROTEM tests to confirm coagulopathy and heparin neutralization. 7. EXTEM/ FIBTEM will be done to evaluate therapeutic response after application of the ROTEM guided transfusion therapy. 8. Blood sample will be taken after protamine administration by 5 minutes (protamine+5) for ACT, antifactor Xa assay, all laboratory tests (CBC, PT, INR, and aPTT ). 16
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients undergoing elective primary cardiac surgery on cardiopulmonary bypass (coronary artery bypass graft, valve replacement or coronary artery bypass graft with valve replacement) - ASA II or III - More than 18 years-old (both sexes) - Emergent cardiac surgeries. - Re-do cardiac surgeries. - Patients taking oral anticoagulants within 5 days of surgery or low molecular weight heparin until the day of surgery. - Patients with congenital or acquired coagulopathy. - Patients with impaired liver functions (elevated liver enzymes) - Patients with impaired renal functions (serum creatinine > 2 mg/dL) - Patients with body mass index < 18 kg/m2 or > 35 kg/m2 Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 79 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 22/07/2019 Research Ethics Committee Faculty of Medicine Suez Canal University
Ethics Committee Address
Street address City Postal code Country
4.5 kilo, The Ring Road Ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Post-bypass blood components transfusion requirements. Post-bypass
Secondary Outcome Postoperative blood loss measured as chest tube drainage after exclusion of surgical cause of bleeding During the first 24 postoperative hours
Secondary Outcome Detecting residual heparin after its reversal with protamine 5 minutes after protamine administration
Primary Outcome Postoperative blood components transfusion requirements During the first 24 postoperative hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal University Teaching Hospital 4.5 kilo, The Ring Road Ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Mahdy The Ring Road Ismailia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Suez Canal University Teaching Hospital 4.5 kilo, The Ring Road Ismailia Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Mahdy ahmed.mahdy@med.suez.edu.eg +201025572557 4.5 kilo, The Ring Road
City Postal code Country Position/Affiliation
Ismailia Egypt Lecturer of Anesthesia and Intensive Care Faculty of Medicine Suez Canal University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Abdel Ghaffar mohamed_abdelghafa@med.suez.edu.eg 00000000000000 4.5 kilo, The Ring Road
City Postal code Country Position/Affiliation
Ismailia Egypt Professor of Anesthesia and Intensive Care Faculty of Medicine Suez Canal University
Role Name Email Phone Street address
Public Enquiries Ahmed Mahdy ahmed.mahdy@med.suez.edu.eg +201025572557 4.5 kilo, The Ring Road
City Postal code Country Position/Affiliation
Ismailia Egypt Lecturer of Anesthesia and Intensive Care Faculty of Medicine Suez Canal University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We intend to share the de-identified individual participants data. All datasets generated and/or analyzed during the current study will be available from the corresponding author on reasonable request. This will begin 12 months and end 36 months following publication of the manuscript. Study Protocol Starting 12 months and ending 36 months following publication of the manuscript Data will be available through direct contact with the corresponding author, to be used for systematic reviews or meta-analyses.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 05/02/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 05/02/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information