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Haemostatic bandages for trauma care

Primary Information

Domain

Healthcare

Project No.

6714

Sanction and Project Initiation

Sanction No: F.No.3-18/2015-T.S.-I

Sanction Date: 19/12/2016

Project Initiation date: 01/04/2017

Project Duration: 36

Partner Ministry/Agency/Industry

Indian Council of Medical Research

 

Role of partner:Because of the medical application, part of the sanctioned grant of the project is supported by the partner agency.

 

Support from partner:The partner support will be to the level of 50% which will play an essential role during the progress of the project in the technology development.

Principal Investigator

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Prof. Ashok Kumar
Department of Biological Sciences and Bioengineering, Indian Institute of Technology Kanpur

Host Institute

Co-PIs

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Dr. Kailash Chand Gupta
Department of Biological Sciences and Bioengineering, Indian Institute of Technology Kanpur

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Prof. (Dr.) Deepak Agrawal
Department of Neurosurgery, JPN Apex Trauma Centre, All India Institute of Medical Sciences, New Delhi

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Prof. (Dr.) Deepak Agrawal
Department of Neurosurgery, JPN Apex Trauma Centre, All India Institute of Medical Sciences, New Delhi

 

Scope and Objectives

The project addresses uncontrolled haemorrhages and its associated severe complications in battlefields and trauma cases that are entailed as one of the primary factors in both defense and civilian deaths. The reports suggest that exsanguinating hemorrhage from survivable injuries leads to half of the deaths in military combat and as a second leading cause of civilian deaths, both of which accounts above 85% of deaths. An ideal haemostatic agent should not only stop the flow of bleeding within minutes but should be bacteriostatic and/or bactericidal. Furthermore, safety, efficacy, usability, cost-effectiveness, ease of manufacturing, absorbability and minimal tissue reactivity are other parameters to be considered for picking an appropriate hemostatic agent. Currently, many haemostatic dressings have been developed and are commercially available, presenting an approach of art as well as science to choose dressings over one another. The major drawbacks of these dressings are expensive, nonavailability, non-antiseptic, and lack of rapid coagulation and may lead to allergic reactions. So, there is an immediate need to develop a dressing material which can have a high haemostatic capacity and should protect the wound from secondary bacterial infections. Thus, we proposed to develop a novel hemostatic bandage that can arrest bleeding rapidly and stabilize the casualty before evacuation to definitive care. The main objectives of the project are as: (1) Development of a ready to use and easy to handle polymeric haemostatic bandage by cryogelation technology. (2) Incorporation of various haemostatic agents to the developed bandage to enhance its efficiency. (3) In-vitro and in-vivo characterization of the bandage for haemostatic efficacy.

Deliverables

The projected deliverables of the innovation will be mainly a novel polymeric haemostatic bandage with antiseptic properties. The developed bandage will be ready-to-use, low cost and will have high blood absorption capacity and optimal mechanical properties. The bandage will not only stop bleeding rapidly but also relieve from a frequent change of bandage due to its high blood absorption capacity.

 

Scientific Output

A single material cannot meet all requirements in clinical use, and hemostatic materials are still far behind in medical demand. So, two strategies followed for developing novel hemostatic materials; one is using specific technologies, to combine the biocompatible and hemocompatible polymer-based materials with other topical haemostatic agents, which can directly activate the coagulation cascade to improve the hemostatic potential. In another one, we modified the polymeric matrix by introducing functional groups onto polymers to achieve rapid and sustained control of a bleeding event without inducing systemic emboli and thromboses. Further other major outcomes of the innovation include: 1. Material development and characterization of haemostatic efficiency. 2. Testing of the materials for blood absorption and clotting efficiency. 3. Polymeric haemostatic bandage having high blood absorption capacity and rapid coagulation of blood. 4. The developed bandage is inexpensive, ready-to-use and antiseptic. 5. Flexible, mechanically robust and high shelf life. 6. The developed bandage can be applied at the injured site by the person himself or any first respondent, thus no need of the trained person. 7. Compiling data for manuscript preparation and any IPR filing.

 

Results and outcome till date

A single material cannot meet all requirements in clinical use and hemostatic materials are still far behind in medical demand. So, two strategies were followed for developing novel hemostatic materials, one is using specific technologies, to combine the biocompatible and hemocompatible polymer-based materials with other topical haemostatic agents, which can directly activate the coagulation cascade to improve the hemostatic potential. In another one, we modified the polymeric matrix by introducing functional groups onto polymers to achieve rapid and sustained control of a bleeding event without inducing systemic emboli and thromboses. Further other major outcomes of the innovation include: 1. Material development and characterization of haemostatic efficiency. 3. Testing of the materials for blood absorption and clotting efficiency. 4. Polymeric haemostatic bandage having high blood absorption capacity and rapid coagulation of blood. 5. The developed bandage is inexpensive, ready-to-use and antiseptic. 6. Flexible, mechanically robust and high shelf life. 7. The developed bandage can be applied at the injured site by the person himself or any first respondent, thus no need of the trained person. 8. Compiling data for manuscript preparation and any IPR filing.

 

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Societal benefit and impact anticipated

The developed product has an enormous potential and market value, as its ingredients are commonly available at the low cost besides being available naturally. The price and availability of the developed product will ensure its high value for more and common people. The material will avoid the use of multiple dressing at the injured site and prevent life-threatening conditions due to excessive bleeding and bacterial infections. The product has the potential to reduce the death toll in trauma cases occurring due to excessive blood loss. Further, the other major beneficial social sectors of the developed product will be 1. Hospitals and educational institutes 2. Pharmaceuticals 3. Medical device and automobile (first aid tool kit) industries

Next steps

Currently, we have completed the study of in-vitro and in-vivo (rat models) for the developed product, and the experimental study proved that the combination of polymeric matrix incorporated with haemostatic agents had integrated the advantages of both materials and provided efficient haemorrhage control by multiple haemostatic performances. The fast and high fluid absorption of the developed matrix was conducive to concentrate platelet and clotting factors, thereby shortening the time lag for initial thrombin generation and the time to peak thrombin generation. However, before the developed product may be processed into a commercially viable product, the clinical evaluation must be completed. So, the product will be tested for clinical trials at AIIMS, New Delhi. The material for clinical testing is being produced in GLP facility present at IIT Kanpur and will be soon tested by the collaborator at AIIMS.

Publications and reports

The manuscript will be communicated after further clinical evaluation of the developed haemostatic sheet.

Patents

The filing of the patent is under process.

Scholars and Project Staff

Syed Muntazir Andrabi (Research Scholar) Anamika Jaiswal (Sr. Project Associate) Surendra Mishra (Project Manager)

Challenges faced

We have to carry out a human trial of our developed product (haemostatic bandage). This part of the project is challenging and will need to develop the product under GLP conditions before its clinical/human evaluation by our clinical collaborator at AIIMS, New Delhi.

Other information

The new generation dressings in the market had already overcome some issue, but the high cost and insufficient provision limited its more extensive application. The developed material will have further distinctions of 'made in India', fabrication, and design and commercialize a ready-to-use Haemostat for trauma care to reduce the mortality due to traumatic bleeding. The aim is an economical and affordable material with a promising potential to fulfill the much-required healthcare needs of the emerging global market.

Financial Information

  • Total sanction: Rs. 112.61 lakhs

  • Amount received: Rs. 85.73 lakhs

  • Amount utilised for Equipment: Rs. 28.47 lakhs

  • Amount utilised for Manpower: Rs. 7.26 lakhs

  • Amount utilised for Consumables: Rs. 14.44 lakhs

  • Amount utilised for Contingency: Rs. 3.13 lakhs

  • Amount utilised for Travel: Rs. 1.51 lakhs

  • Amount utilised for Other Expenses: 0

  • Amount utilised for Overheads: Rs. 14.37 lakhs

Equipment and facilities

 

3D Bioprinter and Tensile Testing Machine