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.: PACTR201406000799322 Date of Approval: 24/03/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effectiveness of dexamethasone as an adjunct to surgery on satisfactory resolution of chronic subdural haematomas: A randomised control trial
Official scientific title The effectiveness of dexamethasone as an adjunct to surgery on satisfactory resolution of chronic subdural haematomas: A randomised control trial
Brief summary describing the background and objectives of the trial Chronic subdural haematoma (CSDH) is a common neurosurgical problem. The use of corticosteroids in the management of CSDH is divided among neurosurgeons. The basis for the use of corticosteroid therapy in CSDH lies in their role in impeding the formation of neo-membranes and neo-capillaries, a major implicator for persistent bleeding in CSDH. The successful treatment of CSDH remains a major problem with only 64-89% of patients undergoing surgery alone, having complete neurological resolution and up to 26% of all patients developing persistent bleeding requiring further surgery. This study proposes to look at the role of corticosteroids as an adjunct to surgery in improving resolution of CSDH via a randomized control trial. The primary objective will be to compare the proportion of patients with satisfactory radiological resolution of chronic subdural haematomas via a CT Scan done at 6 weeks. Secondary Objectives 1) To compare the proportion of patients with clinical resolution via a Markwalder Grading Scale to assess neurological outcome (Appendix 1) 2) To compare the proportion of patients with residual collection requiring a second operation 3) To determine frequency of complications from steroid use
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Chronic subdural haematomas,Nervous System Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/05/2014
Actual trial start date 01/05/2014
Anticipated date of last follow up 28/02/2014
Actual Last follow-up date 28/02/2014
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Not yet 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using a randomisation 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 Dexamethasone Preop 8mg stat , Day 1 4mg tds, Day 2 & 3 4mg bd, Day 4-10 2mg bd, Day 11-24 1mg bd, Day 25-42 0.5mg bd 6 weeks Group 1 25 Active-Treatment of Control Group
Control Group Placebo No dose 6 weeks Placebo 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age above 18 2. Chronic subdural haematoma diagnosed on CT Scan requiring surgical management as determined by the neurosurgeon. 1. Patients who are already on corticosteroids for other reasons 2. Patients with contraindications for corticosteroid use 3. Patient refusal 4. Patients who require early (within 6 weeks) re-commencement of antiplatelet or anti-coagulant therapy as determined by the physician 18 Year(s) 100 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 24/04/2014 Health Research Ethics Committee Aga Khan University Nairobi
Ethics Committee Address
Street address City Postal code Country
3rd Parklands Avenue Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Satisfactory Radiological Resolution 6 weeks
Secondary Outcome 1) To compare the proportion of patients with clinical resolution via a Markwalder Grading Scale to assess neurological outcome 6 weeks
Secondary Outcome 2) To compare the proportion of patients with residual collection requiring a second operation 6 weeks
Secondary Outcome 3) To determine frequency of complications from steroid use 2, 4 and 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University Hospital Nairobi, Kenya 3rd Parklands Avenue Nairobi 00200 Kenya
The Nairobi Hospital Argwings Kodhek Road Nairobi 00200 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Research Support Unit, Aga Khan University Nairobi 3rd Parklands Avenue Nairobi 00200 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Research Support Unit, Aga Khan University Nairobi 3rd Parklands Avenue Nairobi 00200 Kenya University
COLLABORATORS
Name Street address City Postal code Country
The Nairobi Hospital Argwings Kodhek Roard Nairobi 00200 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Carnjini Yogeswaran carnjini.yogeswaran@aku.edu +254717022905 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi 002000 Kenya Resident in Surgery
Role Name Email Phone Street address
Public Enquiries Carnjini Yogeswaran carnjini.yogeswaran@aku.edu +254717022905 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Resident In Surgery
Role Name Email Phone Street address
Scientific Enquiries Carnjini Yogeswaran carnjini.yogeswaran@aku.edu +254717022905 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Resident In Surgery
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