| CTRI Number |
CTRI/2021/04/032665 [Registered on: 08/04/2021] Trial Registered Prospectively |
| Last Modified On: |
08/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to know the effect of low molecular weight heparin in treatment of acute pancreatitis. |
|
Scientific Title of Study
|
Low molecular weight heparin in treatment of moderately severe and severe acute pancreatitis; A randomized control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Laxmi Narayan Meena |
| Designation |
Professor |
| Affiliation |
SMS Medical College and Attached Hospitals, Jaipur |
| Address |
Department of General Surgery
Surgery Unit 4
SMS Hospital
SMS Medical College and Attached group of Hospitals
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
|
| Fax |
|
| Email |
dr.lnmeena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basavaraj |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College and Attached Hospitals, Jaipur |
| Address |
Department of General Surgery, SMS Hospital,
SMS Medical College and Attached Group of Hospitals, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9449468782 |
| Fax |
|
| Email |
basavaraj_kindle@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Basavaraj |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College and Attached Hospitals, Jaipur |
| Address |
Department of General Surgery,
SMS Hospital
SMS Medical College and Attached Group of Hospitals, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9449468782 |
| Fax |
|
| Email |
basavaraj_kindle@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SMS Medical College, Jaipur |
|
|
Primary Sponsor
|
| Name |
SMS Medical Jaipur |
| Address |
SMS Medical College
JLN Marg
Jaipur
302004 |
| Type of Sponsor |
Government 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 |
| Dr Basavaraj |
SMS Hospital Jaipur |
Department of General Surgery, SMS Medical College and Associated Group of Hospitals, Jaipur
Jaipur
RAJASTHAN |
9449468782
basavaraj_kindle@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE SMS MEDICAL COLLEGE JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K859||Acute pancreatitis, unspecified, (2) ICD-10 Condition: K852||Alcohol induced acute pancreatitis, (3) ICD-10 Condition: K851||Biliary acute pancreatitis, (4) ICD-10 Condition: K853||Drug induced acute pancreatitis, (5) ICD-10 Condition: K850||Idiopathic acute pancreatitis, (6) ICD-10 Condition: K858||Other acute pancreatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Treatment only |
Patients of conventional group will receive conventional treatment only. |
| Intervention |
Low molecular weight heparin (Enoxaparin) with conventional treatment |
Low molecular weight heparin in the form of enoxaparin is given at the dose of 1mg/kg body weight 12 hourly along with the conventional treatment for seven days to control group patients. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of moderately severe or severe acute pancreatitis. Admitted within 24hours of onset of symptoms. willing to participate |
|
| ExclusionCriteria |
| Details |
Chronic pancreatitis. Traumatic pancreatitis. Hypersensitivity to low molecular weight heparin, heparin, pork products, benzyl alcohol or other ingredients of enoxaparin preparation or radio contrast agent. Any contraindication for low molecular weight heparin. Pregnancy and lactation. Charlson Comorbidity Index 5 or more |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pancreatic Necrosis |
Baseline and at the end of one week of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical wellbeing(time taken to tolerate oral feeds, time of relief from abdominal symptoms and signs, mean duration of hospital stay) |
During the period of current episode of acute pancreatitis |
| Local and systemic complications |
During the period of current episode of acute pancreatitis |
| Need for surgical, endoscopic or minimal invasive procedure |
During the period of current episode of acute pancreatitis |
| Mortality |
During the period of current episode of acute pancreatitis |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/04/2021 |
| Date of Study Completion (India) |
01/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/12/2021 |
|
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
Modification(s)
|
Patil B, Meena LN, Sharma DC, Agarwal G, Dadhich Y, Gupta G. Impact of low-molecular-weight heparin in the treatment of moderately severe and severe acute pancreatitis; a randomized, single blind, phase 3 control trial. Int J Surg. 2022 May;101:106621. doi: 10.1016/j.ijsu.2022.106621. Epub 2022 Apr 27. PMID: 35489648. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a single centre, hospital based, randomised control trial to
determine the effect of low molecular weight heparin (enoxaparin) on outcome of
moderately severe and severe acute pancreatitis. Study period was two years. Patients
of acute pancreatitis meeting the selection criteria were randomized to control
group and trial group with 70 patients in each group. Control group receives
conventional treatment for acute pancreatitis and control group received
enoxaparin 1mg/kg body weight in addition to the conventional treatment for 7
days. CT scans were done on day0 and day8 of the treatment and other
investigations were done as per standard protocol. Data was recorded in
systematic proforma and the outcomes of both the groups are compared. the
primary outcome was pancreatic necrosis and secondary outcomes compared were
clinical wellbeing, local and systemic complications, need for interventions
and mortality during the current episode of acute pancreatitis. Use of LMWH in early stage of moderately-severe and
severe acute pancreatitis had significant positive impact on all the parameters
that were assessed. |