| CTRI Number |
CTRI/2021/09/036977 [Registered on: 30/09/2021] Trial Registered Prospectively |
| Last Modified On: |
31/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the Safety and Hemostat Efficacy of Absorbable Hemostat Powder |
|
Scientific Title of Study
|
A Prospective, Randomized, Active Controlled, Observer-blind Clinical Study Evaluating the Safety and Hemostat Efficacy of Absorbable Hemostat Powder of Lucktin (Hainan) Biotech Co., Ltd., in comparison with AristaTM AH (Absorbable Hemostat) of Davol, Inc., Subsidiary of C. R. Bard, Inc. in Mild or Moderate Parenchymal or Soft Tissue Bleeding During General Surgery |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HEMO-20-112 Ver 3.0, Dated 20 Jul 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Senthil Kumar |
| Designation |
Head Clinical and Medical Monitor |
| Affiliation |
Scitus Pharma Services Private Limited |
| Address |
2 294 DRR Avenue 2nd Street AUDCO Nagar Kattupakkam Poonamallee Chennai 600056
Tamilnadu India
Thiruvallur
TAMIL NADU
600056
India |
| Phone |
9994689336 |
| Fax |
|
| Email |
senthilkumar.k@scitusbiolab.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Senthil Kumar |
| Designation |
Head Clinical and Medical Monitor |
| Affiliation |
Scitus Pharma Services Private Limited |
| Address |
2 294 DRR Avenue 2nd Street AUDCO Nagar Kattupakkam Poonamallee Chennai 600056
Tamilnadu India
Thiruvallur
TAMIL NADU
600056
India |
| Phone |
9994689336 |
| Fax |
|
| Email |
senthilkumar.k@scitusbiolab.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SD Rajendran |
| Designation |
Director and Head Operations |
| Affiliation |
Scitus Pharma Services Private Limited |
| Address |
2 294 DRR Avenue 2nd Street AUDCO Nagar Kattupakkam Poonamallee Chennai 600056
Tamilnadu India
Thiruvallur
TAMIL NADU
600056
India |
| Phone |
9940306042 |
| Fax |
|
| Email |
sd.rajendran@scitusbiolab.com |
|
|
Source of Monetary or Material Support
|
| Lucktin (Hainan) Biotech Co., Ltd |
|
|
Primary Sponsor
|
| Name |
Lucktin Hainan Biotech Co Ltd |
| Address |
West Side of the Third Floor of No 1 Building No 16 Yaogu Yiheng Road Yaogu Industrial Park High tech Zone Haikou City Hainan China |
| Type of Sponsor |
Other [Medical Device Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Venugopal KJ |
Adichunchanagiri Hospital and Research Center |
Adichunchanagiri Hospital and Research Center Balagangadharanathanagara Belluru Hoblli Nagamangala Taluk Mandya Bengaluru
Mandya
KARNATAKA |
8904606733
venugopalkj@gmail.com |
| Dr Rajesh Kesavan |
Aysha Hospital Pvt Ltd |
Aysha Hospitals Pvt. Ltd.,
91-A, Millers Road, Hussain Complex, Kilpauk,
Chennai, Tamil Nadu – 600010 India.
Chennai
TAMIL NADU |
9360778800
rajkesavdr@gmail.com |
| Dr Suresh Radhakrishnan |
Dr. Rela Institute & Medical Centre |
No. 7, CLC Works Road, Nagappa Nagar, Chromepet,Chennai,
Tamil Nadu - 600044, India.
Chennai
TAMIL NADU |
8056274801
suresh.radhakrishnan@relainstitute.com |
| Dr Suraj Kumar Pattnayak |
Government Medical College & Govt. General Hospital |
Government Medical College and Govt General Hospital Balaga Srikakulam
Srikakulam Andhra Pradesh
532001
Srikakulam
ANDHRA PRADESH |
9000268524
gghsrikakulam@gmail.com |
| Dr Yeshwant Lamture |
J N Medical College DattaMeghe Institute Of Medical Sciences DU |
J.N Medical College DattaMeghe Institute of Medical Sciences DU
Sawangi M Wardha
Wardha
MAHARASHTRA |
8308358648
yash18671@gmail.com |
| Dr Suresh Kumar |
Jawaharlal Institute of Post Graduate Medical Education and Research JIPMER |
Department of Surgery
Jawaharlal Institute of PostGraduate Medical Education and Research JIPMER Dhanvantari Nagar Puducherry 605006
Pondicherry
PONDICHERRY |
9788637893
drsureshkumar08@gmail.com |
| Dr Lovenish Bains |
Maulana Azad Medical College |
Department of Surgery, Maulana Azad Medical College Bahadur Zafar Marg New Delhi Pin 110006
North East
DELHI |
9968604377
lovenishbains@gmail.com |
| Dr V Mahidhar Reddy |
Narayana Medical College And Hospital |
Narayana Medical College And
Hospital Chintareddy Palem
Nellore Andhra Pradesh
524003
Nellore
ANDHRA PRADESH |
9703848030
drmahidarnmc@gmail.com |
| DR AMILTHANK |
New Hope Medical Centre Pvt. Ltd |
New Hope Medical Centre Pvt Ltd,
No.814 Poonamalle High Road, Kilpauk,Chennai – 600 010, Tamil Nadu, India
Chennai
TAMIL NADU |
9841024214
amilthan@gmail.com |
| Dr R Balamurugan |
SRM Medical College Hospital and Research Centre |
SRM Medical College Hospital and Research Centre SRM Nagar Potheri Kattankulathur KANCHEEPURAM
Chennai Kanchipuram
Tamil Nadu 603203
Kancheepuram
TAMIL NADU |
9841434506
drbala.ms@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ethics Committee Narayana Medical College Hospital |
Approved |
| Institutional Ethics Committee |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE MAMC |
Approved |
| Institutional Ethics Committee of AH and RC |
Approved |
| Institutional Ethics Committee of DMIMS |
Approved |
| Dr Rela Institute & Medical Centre Institutional Ethics Committee |
Approved |
| Hycare super speciality hospital ethics committee |
Approved |
| Hycare super speciality hospital ethics committee - New Hope Medical Centre |
Approved |
| IEC Intervention Studies |
Approved |
| SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Y838||Other surgical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Absorbable hemostat powder |
The product is modified plant starch, it has strong capability of water absorption. When in contact with the blood, it can quickly absorb the water molecules in the blood, it’s capability of water absorption is equivalent to the function of hydrophilic molecular sieve. Moreover, it can gather the visible components (such as platelets, etc.) on the surface of the microspheres to accelerate the activation of endogenous coagulation molecules, and the "instant gel" is formed to form a dense fibrin net, which can instantly stop bleeding, and the coagulant block is firm and reliable |
| Comparator Agent |
AristaTM AH
(Absorbable Hemostat) |
AristaTM AH is a medical device intended for application to surgical wound sites as an absorbable hemostat. This technology incorporates hydrophilic, flowable, microporous particles synthesized by cross-linking purified plant starch through a proprietary process; Arista AH is a 100% plant based polysaccharide Arista AH is a fine, dry, sterilized white powder that is biocompatible, non-pyrogenic, and is typically absorbed within 24 to 48 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
I.Pre-operative
1.Male or female subjects aged from 18 to 60 years (both inclusive) requiring elective/non-emergent general surgical procedures (minimally invasive surgery or open surgery).
2.Subject or legally authorized representative has signed the Ethics Committee approved Informed Consent.
3.Subject whose International Normalized Ratio is <1.5 within 24 hours of surgery.
4.The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.
II.Intra-operative
1.Presence of an appropriate target bleeding site (TBS) identified intra-operatively by the surgeon.
2.Subject(s) on anticoagulation undergoing surgery must have anticoagulation reversed prior to target bleeding site (TBS) identification and treatment. |
|
| ExclusionCriteria |
| Details |
I. Pre-operative
1. Female subjects who are pregnant or nursing;
2. Subject on anticoagulation medication (with the exception of aspirin) prior to surgery. Washout periods for respective medications must be observed. If information is not readily available within the Instructions for Use (IFU), a conservative approach should be taken and intravenous heparin stopped 12 hours prior to surgery and 2 days prior for oral medication;
3. Subject on antiplatelet/P2Y12 inhibitors medication prior to surgery. Platelet recovery times for respective medication must be observed. If information is not readily available within the IFU, a conservative approach should be taken and medication stopped 5 days prior to surgery.
4. Subject is currently participating or plans to participate in any other investigational device or drug trial without prior approval from the Sponsor;
5. Subjects who are known, current alcohol and/or drug abusers
6. Subjects with any pre-operative findings identified by the surgeon that may preclude conduct of the study procedure.
7. Subjects requiring neurological and ophthalmic procedures.
8. Subjects with post-partum bleeding or menorrhagia, uncontrolled hypertensive and diabetic patients.
9. History of blood dyscrasias or immunocompromised patients.
10. Known ongoing infection (local or systemic).
11. Subjects with known psychiatric disorder which would preclude him/her from completing the study.
12. Subjects with known congenital or acquired immunodeficiency.
II. Intra-operative
1. Subjects with any intra-operative findings identified by the surgeon that may preclude the use of study device;
2. Subject with target bleeding site (TBS) in an actively infected field [Class III Contaminated or Class IV Dirty or Infected];
3. Target bleeding site (TBS) is on arteries or veins where application of absorbable hemostat powder would present a risk of introducing the study device into an open blood vessel;
4. Major arterial or venous bleeding or major defects in arteries and veins;
5. Target bleeding site (TBS) where silver nitrate or any other escharotic chemicals have been applied, Target bleeding site (TBS) is in, around, or in proximity to foramina in bone, or areas of bony confine, the spinal cord, or optic nerve and chiasm;
6. Target bleeding site (TBS) in urological procedures where plugging (blocking) of the urethra, ureter or a catheter is possible by the study device.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects achieving hemostatic success at 5 minutes following the application of powder with no re-bleeding requiring additional treatment at the target bleeding site (TBS) in each group. |
Intra-operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Proportion of subjects achieving hemostatic success at 3 minutes following the application of powder with no re-bleeding that requires additional treatment at the TBS in each group.
• Proportion of subjects achieving hemostatic success at 10 minutes following the application of powder with no re-bleeding that requires additional treatment at the TBS in each group. |
Intra-operatively |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="360" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/09/2021 |
| Date of Study Completion (India) |
03/04/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
will be a prospective, parallel design, active controlled, observer-blind
multicenter, clinical study comparatively evaluating absorbable hemostat powder
in achieving hemostasis in mild or moderate parenchymal or soft tissue bleeding
during surgery. The main objective of this study is to evaluate the efficacy (as the primary objective) and
safety (as the secondary objective) of the Absorbable Hemostat powder of
Lucktin (Hainan) Biotech Co., Ltd., (test device) in comparison with AristaTM AH
(Absorbable Hemostat) of Davol, Inc.,
Subsidiary of C.R. Bard, Inc. (reference device; active control) in identified mild or moderate soft
tissue/parenchymal bleeding for which conventional methods of control (e.g.,
suture, ligature, and cautery) are ineffective or impractical, and an adjunct
device is required to achieve hemostasis. Approximately 360 subjects
will be randomized to either test or reference device in a targeted 1:1 ratio.
Subjects undergoing open surgery and minimally invasive surgery will be
selected in a targeted 2:1 ratio by stratified randomization technique. Thus,
approximately 240 subjects will be selected from subjects undergoing open
surgery, and approximately 120 subjects will be selected from subjects
undergoing minimally invasive surgery. The test to reference ratio will be
maintained at 1:1. |