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CTRI Number  CTRI/2025/09/095204 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 20/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A trial in head injury patients undergoing brain surgery to test whether clamped drains reduce postoperative complications compared to regular drains. 
Scientific Title of Study   Comparing the efficacy of using a Passive drain versus Clamped drain in reducing postoperative complications following Decompressive Craniectomy in traumatic brain injury patients - A Randomised Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shashikant Prasad 
Designation  Senior Resident Academics 
Affiliation  All India Institute of Medical Science Patna 
Address  Room No 105 First floor Trauma Block AIIMS patna
Room No 105 First floor Trauma Block AIIMS patna
Patna
BIHAR
801507
India 
Phone  8368111747  
Fax    
Email  skprasad25993@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anil Kumar 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Science Patna 
Address  Room No 105 First floor Trauma Block AIIMS patna
Room No 105 First floor Trauma Block AIIMS patna
Patna
BIHAR
801507
India 
Phone  9835699103  
Fax    
Email  dranilk@aiimspatna.org  
 
Details of Contact Person
Public Query  
Name  Dr Shashikant Prasad 
Designation  Senior Resident Academics 
Affiliation  All India Institute of Medical Science Patna 
Address  Room No 105 First floor Trauma Block AIIMS patna
Room No 105 First floor Trauma Block AIIMS patna
Patna
BIHAR
801507
India 
Phone  8368111747  
Fax    
Email  skprasad25993@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Shashikant Prasad 
Address  Room No 105 First floor Trauma Block AIIMS patna Bihar-801507 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shashikant Prasad  All India Institute Of Medical Science   T4 ICU Department of Trauma Surgery and Critical Care Trauma Block AIIMS Patna
Patna
BIHAR 		 8368111747

skprasad25993@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee AIIMS Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S069||Unspecified intracranial injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Clamped drain  Drain will be clamped after decompressive craniectomy for 2 days 
Comparator Agent  Unclamped Drain  Drain will not be clamped for 2 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  i. All patients of Isolated TBI requiring DC between the ages of 18-65 years.
ii. Legally authorized representative of patient giving consent for surgery.
 
 
ExclusionCriteria 
Details  i. Patients with coagulopathy (International normalized ratio more than 1.5) or thrombocytopenia (platelets less than 100 x 103 / µL) ,or recent antiplatelet or anticoagulation’s used in the past 7 days.
ii. Patients with trivial fall diagnosed to be intracerebral haemorrhage secondary to hypertension.
iii. Patients with polytrauma
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To know the advantages and complications(Subgaleal haematoma, Meningitis, Hydrocephalus, Brain Bulge, Fever ,Surgical site infection, Hematoma and need for reoperation) of usage of Drain versus Clamped drain in DC for traumatic brain injury.  Day1 day2 Day3 7th day 1month 3month 
 
Secondary Outcome  
Outcome  TimePoints 
To know the feasibility and possible adversities in using drain in comparison to clamped drain in DC for management of traumatic brain injury .  18 MONTHS 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  06/10/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This randomized controlled trial titled “Comparing the efficacy of Passive drain versus Clamped drain in reducing postoperative complications following Decompressive Craniectomy in traumatic brain injury patients” will be conducted at AIIMS Patna to address the ongoing controversy regarding routine drain use after decompressive craniectomy (DC). Traumatic brain injury (TBI) is a major cause of morbidity and mortality, and although DC is effective in controlling raised intracranial pressure, postoperative complications such as subgaleal hematoma, surgical site infection, hydrocephalus, and need for reoperation remain frequent. While passive drains are traditionally used, they may increase risks without improving functional outcomes, and no clear guidelines exist regarding their use or clamping. The study will enroll 94 adult patients (18–65 years) with isolated TBI requiring DC, randomized equally into two groups: passive drain versus clamped drain. Block randomization with sealed envelopes will ensure allocation concealment. Standardized DC will be performed in all cases, with drains removed on the second postoperative day if imaging is satisfactory; in the clamped group, drains will remain closed unless neurological deterioration occurs. Outcomes assessed will include postoperative complications, mortality, and 3-month neurological status using the Glasgow Outcome Scale–Extended. Data will be analyzed using appropriate statistical tests with p < 0.05 considered significant. We expect that clamped drains will be as safe as passive drains while minimizing infection and hydrocephalus risk, thereby contributing evidence to inform clinical practice, optimize outcomes, and guide future recommendations. 
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