Skip to content

Single Dose vs Double dose of low molecular weight heparin in treatment of Severe Acute Pancreatitis

Once daily vs twice daily dose of low molecular weight heparin in treatment of severe acute pancreatitis: A randomized, controlled, open-label, pilot study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030610
Enrollment
50
Registered
2021-01-20
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K859- Acute pancreatitis, unspecified

Interventions

Intervention1: Patients in the twice daily arm will receive, in addition, enoxaparin sodium 1 mg/kg twice daily (the recommended therapeutic dosage in deep vein thrombosis and pulmonary embolism), fro

Sponsors

ILBS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All adult cases of severe acute pancreatitis , who do not match exclusion criteria ,admitted to ILBS during study period will be included in the study .

Exclusion criteria

Exclusion criteria: Patients with: -chronic pancreatitis. -hypersensitivity to LMWH -Pregnant or breast feeding ladies - pediatric age group - prior coagulopathy. - CLD with acute pancreatitis. - Stroke/ CVA(Cerebro-Vascular Accident) - Established SP axis thrombus - Presentation beyond 10 days from onset of pancreatitis

Design outcomes

Primary

MeasureTime frame
Objective comparison of clinical degree of severity and organ failure scores in the two arms as evaluated by SOFA, APACHE II scores at day 7 and day 14 of therapyTimepoint: Baseline, Day 7 and Day 14 of therapy.

Secondary

MeasureTime frame
1.In hospital mortality. 2.Duration of ICU Stay 3.Duration of Hospital stay 4. Thrombotic complications- SPM-axis thrombosis 5.Haemorrhagic complications- GI haemorrhage, Intra-pancreatic haemorrhage, Post intervention haemorrhage. 6.Need for IR, MIS, Surgery for local complications. 7.Coagulopathy: Changes in ROTEM 8.CRP level at day 3, 7, 14 Timepoint: At admission, day 3, day 7, day 14 and throughout hospital stay depending upon parameter as mentioned in secondary outcome parameteres.

Countries

India

Contacts

Public ContactDr Shridhar Vasantrao Sasturkar

ILBS , Vasant Kunj

svsasturkar@gmail.com9910461303

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026