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CTRI Number  CTRI/2018/02/012239 [Registered on: 28/02/2018] Trial Registered Retrospectively
Last Modified On: 03/12/2018
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   A Post Marketing study of VELSEAL-T to control the bleeding from severely bleeding wounds due to accidents, trauma cases and after angiography / angioplasty 
Scientific Title of Study   VELSEAL - T: A phase 4 clinical trial to evaluate Safety and Efficacy of “VELSEAL - T”to Achieve Haemostasis in Traumatic or Surgical Wound, both venous and arterial bleeds and after angiography / angioplasty. 
Trial Acronym  VELSEAL-T 
Secondary IDs if Any  
Secondary ID  Identifier 
HAEM/GCR/01/14, V 2.0, Date: 13th Apr 2015  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Rajan Datt 
Designation  Managing Director  
Affiliation  Datt Mediproducts Private Limited 
Address  56, Community Centre, East Of Kailash

South
DELHI
110065
India 
Phone  011-47191777  
Fax    
Email  rajan.datt@dattmedi.com  
 
Details of Contact Person
Public Query  
Name  Dr Archana Kelkar 
Designation  Medical Writer 
Affiliation  Genelife Clinical Research 
Address  Office no. 12, Ground Floor, Evershine Mall, ChincholiBunder,
New Link Road, Malad (West
Mumbai
MAHARASHTRA
400064
India 
Phone    
Fax    
Email  archanakelkar18@gmail.com  
 
Source of Monetary or Material Support  
Datt Mediproducts Private Limited 56, Community Centre, East Of Kailash New delhi – 110065, India 
 
Primary Sponsor  
Name  Datt Mediproducts Private Limited 
Address  56, Community Centre, East Of Kailash New delhi – 110065, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mukund Deshpande  Government Medical College, Nagpur  Government Medical College and Superspecialty Centre, Nagpur – 440003.
Nagpur
MAHARASHTRA 		 9823056562

drmukunddeshpande@gmail.com 
Dr Santanu Dutta  Institute of Post Graduate Medical Education and Research  Institute of Post Graduate Medical Education and Research, 244 A.J.C Bose Road, Kolkata, West Bengal 700020
Kolkata
WEST BENGAL 		 9830808666

dr.santanudutta@gmail.com 
Dr Jitendra Kumar Kushwaha  King George’s Medical University  King George’s Medical University, Shah Mina Road, Chowk, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH 		 9935945852

jkkushwaha@gmail.com 
Dr Praveen Maddirala  Praveen Cardiac Centre  ,#32-9-18, Moghalarajapuram, Madhu Garden Centre, No. 5 Bus Route, Vijayawada – 520 010
Krishna
ANDHRA PRADESH 		 866-2444440

drpraveen.pcc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee – Department of Pharmacology Government Medical College Nagpur  Approved 
Institutional Ethics Committee King George’s Medical University – Lucknow  Approved 
Institutional Ethics Committee, Praveen Cardiac Centre.  Approved 
IPGME & R Research Oversight Committee, Kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T889||Complication of surgical and medical care, unspecified, Patients with severely bleeding wounds such as accidents, trauma cases, deep arterial wounds and after angiography / angioplasty,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  N/A  N/A 
Intervention  VELSEAL-T  VELSEAL - T is an innovative medical device for severe bleeds and traumatic bleeding. It is consists of Tranexamic Acid, Chitosan, Gelatin and Thrombin. These constituents are held in the vesicular voids of the matrix, on the internal surface. This enables the rapid coagulation when blood flows into the dressing, leading to sealing and stabilization of wound surfaces. The highly porous structure in the VELSEAL - T results into interconnected small voids, provides a large surface area and micro-areas for reactions to occur and thus exerts a pseudo-catalytic effect on blood clotting till the blood clotting process – the coagulation cascade – is activated. The device is approved for marketing / free production 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Males and females above 18 years of age who require haemostasis control for traumatic injuries, both venous and arterial bleeds and after angiography/angioplasty.

2.Subjects who can provide informed consent form in writing and medically in a position to undergo consent and screening processes.

3. The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.
 
 
ExclusionCriteria 
Details  1. Subjects who present with medical emergency, where treatment is more priority than the informed consent process.

2. Subjects who cannot provide informed consent such as unconscious subjects.

3. The subjects who have been treated with other higher treatment for Haemorrhage control such as Tourniquets for more than 2 hours, Blood or platelet-rich-plasma transfusion etc.

4. Subjects with haematocrit less than 38% or haemoglobin less than 10 gm%.

5. Subjects with known haemorrhagic disorders like GI bleeding, Ante partum haemorrhage, metropathia haemorrhagica, history of haematemesis, haematuria, epistaxis etc.

6. Known cases of genetic bleeding disorder.

7. Subjects who have platelet count one thousand or more below the lower normal limit.

8. Subjects with known possible loss of plasma or blood from other areas than wound such as lacerations, uterine bleeding, gastro-intestinal bleeding etc.

9. The subject has an active infection at the surgical site.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of the VELSEAL - T Device in controlling Haemorrhage from traumatic injuries, both venous and arterial bleeds and after angiography/ angioplasty.  with in 10 minutes of application of Velseal-T 
 
Secondary Outcome  
Outcome  TimePoints 
a. Proportion of population demonstrating failure of hemorrhage control within 20 minutes after VELSEAL-T application.
b. Proportion of population demonstrating secondary hemorrhage after removal of VELSEAL-T.
c. Average time taken for control of the bleeding.
d. Average weight change of the device material before application and after removal from the wound. 		 20 minutes for hemorrhage control.
upto 4 hours - followup for safety 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   06/01/2016 
Date of Study Completion (India) 06/10/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="5"
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  
This is an open label, phase 4 , single arm clinical trial with a primary objective of :
To evaluate the efficacy of the VELSEAL - T Device in controlling Haemorrhage from traumatic injuries, both venous and arterial bleeds and after angiography/ angioplasty.
and its secondary Objectives is 
o Assessment of safety of device (adverse events)
o  Assessment of Device success (defined as the percentage of first bleeding site applications for which hemostasis was obtained within 10 minutes of study device application).
o Assessment of Number of VELSEAL - T used on a single wound until complete haemostasis.
o To evaluate average time taken after application of VELSEAL - T device for control of Haemorrhage.
o Global assessment of study medications by Investigators.

Sample size calculation and study Hypothesis : 
The studies conducted in Interventional Cardiology set-up to establish the safety and efficacy of the devices on basis of Events (haemorrhage, hematoma and abrasions) were found to be 7.2% in 400 subjects. This value is used for margin of error calculation; 0.05 Margin of error is for 95% CI.
To calculate performance goal, both margins are merged with the initial reference value and maximum event rate of 12.25% was obtained. Taking This value in reference, the proportion based Normal Curve was obtained on Minitab. The power of 80% is maintained on comparator p from 0.12 to 0.18. Hence, Proportion of population who continue with Haemorrhage at treated site beyond 10 minutes was planned to be less than 16%. This value was set as a performance Goal (Alternate Hypothesis: less than). 
Thus Null Hypothesis was set as 
H0 = M1 – M2 = 0,
where M2 is actual proportion of events and M1 is performance goal = 16% Alternate Hypothesis was set as:
H1 = M1-M2 > 0 With this the calculated sample size at 95% CI, upper bound and 80% power was 100. Adding 20% drop-outs, the final sample is calculated as 120.
 
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