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.: PACTR201805003406118 Date of Approval: 22/05/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Novel Adverse Effect of Tranexamic Acid in Adolescent Idiopathic Scoliosis Surgery
Official scientific title A Novel Adverse Effect of Tranexamic Acid in Adolescent Idiopathic Scoliosis Surgery
Brief summary describing the background and objectives of the trial Background: Recently, animal studies uncovered that tranexamic acid (TXA) arouses pain by inhibiting ¿-aminobutyric acid and glycine receptors on dorsal horn neurons of the spinal cord. Inspite of the fact that TXA is routinly used to reduce perioperative blood loss, its capability to induce intraoperative nociception, thereby increasing the need for more analgesics during surgery, has not been researched Aims: This study intended to investigate whether TXA elicits pain and increases the requirement for higher intraoperative analgesic needs
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Scoliosis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/03/2018
Actual trial start date 01/02/2018
Anticipated date of last follow up 01/06/2018
Actual Last follow-up date 01/06/2018
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants) 75
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
FMASU r 48/2017 FWA 000017585
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Numbered containers Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a radomisation table created by a computer software program Numbered containers 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 Control Group patients received normal saline. All through operation Placebo 25 Placebo
Experimental Group Group HD (High Dose) loading dose 50mg/kg , maintenance dose 20mg/kg/h All through operation High dose tranexamic acid 25
Experimental Group Group LD (Low Dose) loading dose 10mg/kg , maintenance dose 1mg/kg/h All through operation Low dose tranexamic acid 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
This randomized controlled clinical trial will be conducted on 75 patients with American Society of Anesthesiologists (ASA) physical status I and II, of either sex, 12-18 years of age, who will be scheduled for elective single stage posterior spine fusion surgery for idiopathic scoliosis under general anesthesia. Patients known to have renal or hepatic disorder, bleeding diathesis, thromboembolic event 1 year prior to surgery, preoperative anemia (hemoglobin < 11 g/dL in females; hemoglobin < 12 g/dL in males), preoperative platelet count < 150,000/mm3, International Normalized Ratio (INR) > 1.4 and history of uncontrolled hypertension will be dismissed from the study. Additionally, patients with neuromuscular disease, congenital or syndromic scoliosis or surgery performed via either combined anterior and posterior spinal fusions or the anterior procedure are excluded. Severe pulmonary disease, i.e., FEV1 < 50% normal will be also excluded from the study Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 12 Year(s) 18 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 27/12/2017 Ain Shams University Research ethical committee
Ethics Committee Address
Street address City Postal code Country
Abbasseya Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total dose given of intraoperative fentanyl At the end of the operation
Secondary Outcome Intraoperative blood loss, time of surgery and perioperative complications At the end of operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Abbaseya Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain Shams University Abbaseya Cairo 11591 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Abbaseya Cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Raham Hasan Mostafa Nasr City Cairo 11727 Egypt
Ashraf Nabil Saleh Nasr City Cairo 11727 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Raham Hasan Mostafa rahamhasan@yahoo.com 002 01222530020 Nasr City
City Postal code Country Position/Affiliation
Cairo 11727 Egypt Lecturer of Anesthesia Ain Shams University
Role Name Email Phone Street address
Public Enquiries Ashraf Nabil Saleh ashraf_nabil95@yahoo.com 002 010001100613 Nasr City
City Postal code Country Position/Affiliation
Cairo 11727 Egypt Lecturer of Anesthesia Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Ashraf Nabil Saleh ashraf_nabil95@yahoo.com 002 010001100613 Nasr City
City Postal code Country Position/Affiliation
Cairo 11727 Egypt Lecturer of Anesthesia Ain Shams University
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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