| CTRI Number |
CTRI/2025/07/090746 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of knowledge regarding Anticoagulation therapy |
|
Scientific Title of Study
|
Study to assess knowledge regarding Anticoagulation therapy among cardiac patient. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Priyanka Niranjan Gotekar |
| Designation |
Postgraduate Student |
| Affiliation |
Datta Meghe Institute Of Higher Education & Research |
| Address |
Department Of Medical Surgical Nursing Smt. Radhikabai Meghe, Memorial College Of Nursing Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7066530692 |
| Fax |
|
| Email |
priyankagotekar2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Arati Rajendra Raut |
| Designation |
Assisstant Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education & Research |
| Address |
Department Of Medical Surgical Nursing Smt. Radhikabai Meghe, Memorial College Of Nursing Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9673771592 |
| Fax |
|
| Email |
aratiraut15714@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Arati Rajendra Raut |
| Designation |
Assisstant Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education & Research |
| Address |
Department Of Medical Surgical Nursing Smt. Radhikabai Meghe, Memorial College Of Nursing Sawangi Meghe
MAHARASHTRA
442001
India |
| Phone |
9673771592 |
| Fax |
|
| Email |
aratiraut15714@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education and Research , Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Sawangi Meghe , Wardha, India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Priyanka Gotekar |
Acharya Vinoba Bhave Rural Hospital |
Dept. of Medicine and Surgery, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA |
7066530692
priyankagotekar2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute Of Higher Education and Research(DU),Sawangi( Meghe),Wardha. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Atrial fibrilliation
2.Deep Venous thrombosis
3.Pulmonary embolism
4.Atrial Fibrilliation
5.Antiphospholipid syndrome |
|
| ExclusionCriteria |
| Details |
1. Bleeding in the gastrointestinal tract, genitourinary, respiratory, and central nervous system
2. haemorrhage
3. Recent surgeries that have a low risk of bleeding.
4. Coagulopathy, thrombocytopenia
5.Recent brain, eye, or spinal cord surgery.
6. Pregnancy
7. Malignant Hypertension
8. Cerebrovascular accident, Intracranial bleeding
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increased Knowledge about anticoagulation therapy among cardiac patients |
Assessments will be done at the end of 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
25/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
A descriptive study will be carried out on patients who are cardiac patients undergoing pulmonary embolism, deep vein thrombosis, stroke, atrial fibrillation in Acharya Vinoba Bhave Rural Hospital and Shalinitai Meghe Super Speciality Hospital, Sawangi (Meghe), Wardha district. It will evaluate knowledge
according to the structured knowledge questionnaire on knowledge regarding anticoagulant therapy. |