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CTRI Number  CTRI/2018/03/012373 [Registered on: 06/03/2018] 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 to control the bleeding from severely bleeding wounds due to accidents, trauma cases and deep arterial wounds. 
Scientific Title of Study   A Phase 4 clinical trial to evaluate safety and efficacy of "Velseal" to achieve Haemostasis in traumatic or surgical wound, both Venous and arterial bleeds. 
Trial Acronym  VELSEAL 
Secondary IDs if Any  
Secondary ID  Identifier 
HAEM/GCR/02/14 V 2.0, Date 15 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  
Name  Dr Rajan Datt 
Designation  Managing Director 
Affiliation  Datt Mediproducts Pvt. Ltd. 
Address  Datt Mediproducts Pvt. Ltd. 56, Community Centre,
East Of Kailash, New Delhi-
South
DELHI
110065
India 
Phone  011-47191777  
Fax    
Email  rajan.datt@dattmedi.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajan Datt 
Designation  Managing Director 
Affiliation  Datt Mediproducts Pvt. Ltd. 
Address  Datt Mediproducts Pvt. Ltd. 56, Community Centre,
East Of Kailash, New Delhi-

DELHI
110065
India 
Phone  011-47191777  
Fax    
Email  rajan.datt@dattmedi.com  
 
Source of Monetary or Material Support  
Datt Mediproducts Pvt Ltd. 56, Community Centre, East Of Kailash, New Delhi- 110065, India 
 
Primary Sponsor  
Name  Datt Mediproducts Pvt Ltd 
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 = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Raj Gajbhiye  Government Medical College, Nagpur,   Professor and Head, Department of Surgery, Government Medical College, 1-A, Hanuman Nagar, Nagpur, Maharashtra 440009
Nagpur
MAHARASHTRA 		 9422101440

rajgajbhiye@hotmail.com 
Dr Jitendra Khushwaha  King George’s Medical University,   Associate Professor, Department of Surgery (G), King George’s Medical University, Shah Mina Road, Chowk, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH 		 9935345852

drjkkushwaha@gmail.com 
Dr Prasada Rao  Rajiv Gandhi Institute of Medical Science & Government General Hospital   I/C. Prof of Surgery, Department of Surgery, Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital, Shanti Nagar Colony, Balaga,
Srikakulam
ANDHRA PRADESH 		 8942279033

prasadrao.dasari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ethics Committee Rajiv Gandhi Institute of Medical Sciences and RIMS Government General Hospital   Approved 
Institutional Ethics Committee – Department of Pharmacology Government Medical College Nagpur.  Approved 
Institutional Ethics Committee King George’s Medical University – Lucknow.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T888||Other specified complications of surgical and medical care, not elsewhere classified, Patients who require haemostasis control for traumatic injuries, both venous and arterial bleeds.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  VELSEAL  VELSEAL is an innovative haemostatic device for severe bleeds. VELSEAL is foam based medical device for control of traumatic bleeding that consists of foam impregnated with anti-fibrinolytic agent. These constituents are held in the vesicular voids of the matrix, on the internal surface sponge. This enables the rapid coagulation when blood flows into the device, leading to sealing and stabilization of wound surfaces. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 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.
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   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of the VELSEAL Device in controlling Hemorrhage from traumatic injuries, both venous and arterial bleeds.  within 10 minutes of study device application 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of Population demonstrating failure of Hemorrhage control within 20 minutes after application of the device.
Proportion of Population demonstrating secondary Hemorrhage after removal of VELSEAL.
Proportion of Population with fall in haemocrait more than 20% of the baseline in case of surgical wound and 10% in case of the traumatic wound or Episiotomy, where bleeding cannot be attributed to any cause other than the wound-bleeding
 		 with in four hour of application 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "101"
Final Enrollment numbers achieved (India)="101" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   09/10/2015 
Date of Study Completion (India) 07/09/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="30" 
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, single arm PMS study with a primary objective:

To evaluate the efficacy of the VELSEAL in controlling Hemorrhage from traumatic injuries, both venous and arterial bleeds.

 Secondary objectives of study are  

Assessment of safety of VELSEAL (adverse events).

Assessment of VELSEAL success (defined as the percentage of first bleeding site applications for which hemostasis obtained within 10 minutes of study device application).

Assessment of number of VELSEAL used on a single wound until complete haemostasis.

Assessment of device-related adverse events.

To evaluate average time taken after application of VELSEAL for control of hemorrhage

  

Sample size calculation and study Hypothesis : 

As per published reference, A study was 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 were merged with the initial reference value and maximum event rate of 12.25% was obtained. Taking that 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 size was calculated as 120. Hence, a sample size of 100 subjects was planned for this study.

 
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