| CTRI Number |
CTRI/2025/07/090118 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Safety and efficacy of StopBleed® hemostatic dressing in controlling external bleeding |
|
Scientific Title of Study
|
Safety and Efficacy of StopBleed Hemostatic dressing in controlling external bleeding. |
| 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 Avinash Parthasarthy |
| Designation |
Medical Superintendent |
| Affiliation |
Sanjay Gandhi Institute of Trauma and Orthopaedics |
| Address |
Medical Superintendent Room, Admin Block, Sanjay Gandhi Institute of Trauma and Orthopaedics, Byrasandra Main Rd, behind Nimhans Hospital, CHCS Layout, 1st Block, Jaya Nagar East, Jayanagar
Bangalore
KARNATAKA
560011
India |
| Phone |
9845023326 |
| Fax |
|
| Email |
dravinash.orth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shekar Mudramaiah |
| Designation |
Chief Medical Officer |
| Affiliation |
Sanjay Gandhi Institute of Trauma and Orthopaedics |
| Address |
Room No 2, OPD Block, Sanjay Gandhi Institute of Trauma and Orthopaedics, Jayangar, Bangalore
Bangalore
KARNATAKA
560011
India |
| Phone |
9448048270 |
| Fax |
|
| Email |
drshekar_m4@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Kaushik M Gawali |
| Designation |
Chief Research Officer |
| Affiliation |
ClinEra Research Solutions |
| Address |
Room No 1, Ground Floor, Clinical Operations Department, 32-80/P2/F-508, Venkateshwara Lake Front, Sainik Nagar, Ramakrishnapuram, Neredmet, Secunderabad
Hyderabad
TELANGANA
500056
India |
| Phone |
09959279640 |
| Fax |
|
| Email |
kaushik.gawali@cliniera.in |
|
|
Source of Monetary or Material Support
|
| Miraqules MedSolutions Private Limited, H. No.: 111, Subhaspally Road, Burdwan – 713101, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
Miraqules MedSolutions Private Limited |
| Address |
H. No.: 111, Subhaspally Road, Burdwan – 713101, West Bengal., India |
| Type of Sponsor |
Other [Medical Device Manufacturing Company - Private Limited] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Avinash Parthasarthy |
Sanjay Gandhi Institute of Trauma and Orthopaedics |
Medical Superintendent Room, Ground Floor, Admin Block, Byrasandra Main Rd, behind Nimhans Hospital, CHCS Layout, 1st Block, Jaya Nagar East, Jayanagar, Bengaluru, Karnataka 560011
Bangalore
KARNATAKA |
9845023326
dravinash.orth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Sanjay Gandhi Institute of Trauma and Orthopaedics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sterile Cotton Gauze |
Sterile Cotton Guaze will be
applied on the wound for a
minimum of 2 minutes and a
maximum of 30 minutes.
Hemostasis will be assessed
based on the time taken to
achieve cessation of bleeding
and the need for additional
interventions. The total duration of the comparator agent would be 2 mins. |
| Intervention |
StopBleed® hemostatic dressing |
StopBleed hemostatic dressing
will be applied on the wound for a minimum of 2 minutes and a maximum of 30 minutes. Hemostasis will be assessed
based on the time taken to achieve cessation of bleeding and the need for additional interventions. The total duration of the intervention would be 2 mins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: Adults aged 18 to 60 years.
2. Wound characteristics: Subjects with Wounds in scalp, upper and lower extremities at the time of baseline assessment with:
3. Mild diffuse bleeding OR Moderate to severe bleeding with bleeding site less than 10 cm2 According to a validated bleeding scale.
4. Subjects or their legal representative who is willing to provide informed consent as approved by the IRB/IEC to participate. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary endpoint of study is time taken to achieve hemostasis in the bleeding wound. It is the summation of the total time spent on compressing the wound to achieve haemostasis.
Primary safety endpoint of this study is the occurrence of secondary ooze of blood after the dressing is being removed as per the IFU. |
1. 2 Minutes (Primary Efficacy End points)
2. 2 Minutes (Primary safety end point) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Volume of blood loss for each group during assessment of hemostasis via gravimetric evaluation.
2. Number of Applications (StopBleed or Gauze) required to achieve hemostasis.
3. Rebleeding & time & frequency of occurrence within 30 minutes after initial cessation of bleeding.
4. Adverse events related to treatment (StopBleed or control) application till 30 days via a passive follow up.
|
1. 30 Mins
2. 48 Hours
3. 30 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
14/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Trauma remains one of the leading causes of death and disability in the world. Around 40% of
deaths in trauma are due to bleeding or its consequences, establishing hemorrhage as the most
common cause of preventable death in this clinical group.
StopBleed® is a biocompatible biopolymeric material available in powder and pellet form as a
hemostatic dressing. StopBleed® is a fibrous material with an extremely high surface area and an
absorption capacity of >3000%. It is applied directly to the wound, where, after coming into contact
with blood, it quickly absorbs plasma and aggregates the blood cells and entraps them in its fibrous
mesh forming a clot that acts as a mechanical barrier at the bleeding site and stops the bleeding.
This mechanism promotes hemostasis independently of the coagulation pathways. The absorption
of the blood also causes the concentration of the clotting factor, which triggers the extrinsic pathway
and further accelerates the blood coagulation.
To date, StopBleed® has been extensively tested through different studies needed in terms of
design verification and validation to prove its safety and efficacy in vitro and in vivo, including all
classes of animals such as mice, rabbits, and pigs. As most of the research on StopBleed® has
been conducted in vitro or in animals, the role of StopBleed® in civilian trauma care is unexplored.
Therefore, to address this requirement, we propose conducting the first-in-human trial of
StopBleed® |