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.: PACTR201611001846189 Date of Approval: 02/11/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Role of Tranexamic Acid Reduces Perioperative Blood Loss in Spine Surgery
Official scientific title Prophylactic Dose of Tranexamic Acid Reduces Perioperative Blood Loss in Spine Surgery: A comparison between two different doses.
Brief summary describing the background and objectives of the trial The study aim was to detect the influence of tranexamic acid in high dose and low on the bleeding in surgery and to ascertain whether the expected reduction in the bleeding was capable of reducing the need for blood transfusion.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied postoperative blood loss,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 02/04/2014
Actual trial start date 20/04/2014
Anticipated date of last follow up 03/04/2016
Actual Last follow-up date 04/05/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 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 Group C received normal saline. 30 min. before operation 20 Placebo
Experimental Group Group HD 50 mg/kg of body weight then 20 mg/kg/h 30 min. before operation loading dose of 50 mg/kg of body weight, administered over the 30-minute period prior to making the skin incision. After the incision has been made, continual infusion is maintained at the rate of 20 mg/kg/h until the end of the procedure, i.e. when the skin has been closed 20 Dose Comparison
Experimental Group Group LD 10 mg/kg of body weight then 1 mg/kg/h 30 min. before operation loading dose of 10 mg/kg of body weight, administered over the 30-minute period prior to making the skin incision, continual infusion is maintained at the rate of 1 mg/kg/h until the end of the procedure, i.e. when the skin has been closed 20 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ages ranged between 28: 65 years ASA I and II BMI < 35 kg/m2 Posterior arthrodesis with fusion of one or two levels uncontrolled hypertension liver or renal impairment congenital or syndromic scoliosis fixation of more than 2 levels Previous spinal surgery coagulopathies patients who received anticoagulant or any drug that may interfere with the study drugs 28 Year(s) 65 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 03/03/2015 Benha Univerisity
Ethics Committee Address
Street address City Postal code Country
Farid nada Benha 230280 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The total amount of blood loss intraoperative and in the first 24 hours postoperative
Secondary Outcome Hemoglobin concentration preoperative and one day postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benha Univerisity Hospitals Farid Nada Benha 230280 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Benha university Farid Nada st. Benha 230280 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine, Benha university Farid Nada st. Benha 230280 Egypt Hospital
Secondary Sponsor Benha university Farid Nada st. Benha 230280 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Neurosurgery department Farid Nada st. Benha 230280 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Mosaad amosaad75@gmail.com 00201003304881 Kafr taha - shebin Elkanater
City Postal code Country Position/Affiliation
shebin Elkanater 13792 Egypt lecturer of anaesthesia
Role Name Email Phone Street address
Public Enquiries Ahmed Abd El-Hamid bashaahmad@yahoo.com +201005204130 Ezz Eldin Omar st.
City Postal code Country Position/Affiliation
Giza 12111 Egypt assistant professor
Role Name Email Phone Street address
Scientific Enquiries saad Ibrahim saadibrahim_7@yahoo.com +201223142889 oman st.
City Postal code Country Position/Affiliation
aldoky 12611 Egypt profossor
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