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CTRI Number  CTRI/2017/08/009499 [Registered on: 25/08/2017] Trial Registered Retrospectively
Last Modified On: 25/08/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Topical Heparin for the prevention of Infusion Associated Superficial Venous Thrombophlebitis A prospective open label comparative clinical study 
Scientific Title of Study   A PROSPECTIVE RANDOMIZED EVALUATOR BLINDED, ACTIVE CONTROLLED PARALLEL GROUP CLINICAL STUDY TO EVALUATE SAFETY AND EFFICACY OF HEPARIN SODIUM TOPICAL SOLUTION (1000 IU/ ML) COMPARED TO HEPARIN SODIUM (200 IU/ GM) TOPICAL GEL IN PREVENTION OF INFUSION ASSOCIATED PHLEBITIS  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vikas Saini 
Designation  Associate professor department of Anestheseology and Intensive care 
Affiliation  PGIMER 
Address  Department of Anestheseology and Intensive care 2nd floor PGIMER Chandigargh sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  91-7087008119  
Fax    
Email  vsainidr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vikas Saini 
Designation  Associate professor department of Anestheseology and Intensive care 
Affiliation  PGIMER 
Address  Department of Anestheseology and Intensive care 2nd floor PGIMER Chandigargh sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  91-7087008119  
Fax    
Email  vsainidr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vikas Saini 
Designation  Associate professor department of Anestheseology and Intensive care 
Affiliation  PGIMER 
Address  Department of Anestheseology and Intensive care 2nd floor PGIMER Chandigargh sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  91-7087008119  
Fax    
Email  vsainidr@gmail.com  
 
Source of Monetary or Material Support  
Not Applicable 
 
Primary Sponsor  
Name  PGIMER 
Address  PGIMER chandigargh sector 12 
Type of Sponsor  Government medical college 
 
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 vikas saini  PGIMER  Department of Anestheseology and Intensive care 2nd floor chandigargh sector 12
Chandigarh
CHANDIGARH 		 91-7087008119

vsainidr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee PGIMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  infusion associated superficial venous thrombophlebitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Phlebotroy QPS  heparin sodium 1000 iu per ml topical solution 
Comparator Agent  Thrombophob gel  heparin sodium 200 iu per gram topical gel 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Planned to undergo peripheral vein cannulation that has been planned to remain in situ for at least 72 hours of indoor period
2 Willing & able to comply with study requirements, e.g. application of IP and study visit schedule, as indicated by written informed consent provided by the patient.
3 If female of childbearing potential: non-pregnant (supported by negative urine pregnancy test at screening), non-lactating and willing to maintain reliable birth control throughout the study.
 
 
ExclusionCriteria 
Details  1 Undergoing re-cannulation due to phlebitis at earlier cannulation site
2 History of hypersensitivity reaction to heparin or heparin induced thrombocytopenia
3 Signs of systemic infection, bacteremia
4 Planned administration of any of the following during study period
Anti-coagulants locally (in the cannula) or systemically
NSAIDs locally (in the cannula or over surrounding area) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1 Proportion of patients with no phlebitis (Grade 0) at the end of 72 hours of treatment period
2 Proportion of patients who developed first signs of infusion phlebitis (Grade I and II) during the 72 hours of treatment period  		 Enrolled patients will be periodically monitored by evaluator every 8 hours from cannulation for infusion phlebitis grade as per visual infusion phlebitis scale
time points are 0 8 16 24 32 40 48 56 64 72  
 
Secondary Outcome  
Outcome  TimePoints 
Mean time to reach infusion phlebitis grade I and II in hours based on the time point when patient was first found to have phlebitis grade I or II. Only the proportion of patients who developed grade I and II phlebitis were considered for the evaluation of mean time to develop grade I and II phlebitis  time points are 0 8 16 24 32 40 48 56 64 72 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "74"
Final Enrollment numbers achieved (India)="74" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   21/12/2015 
Date of Study Completion (India) 06/12/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   In this study, topical heparin was effective in reducing the incidence of development and progression of infusion related superficial venous thrombophlebitis.  Topical heparin solution had significantly higher proportion of patients in whom no signs of phlebitis developed at the end of 72 hours, when compared to heparin gel. In other words, topical heparin therapy was effective in preventing infusion related SVT in patients with in situ catheter for 72 hours. 
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