A clinical study to evaluate the safety and efficacy of Heparin Injection for prophylaxis and treatment as anticoagulant and thrombolytic in Deep Vein Thrombosis and Pulmonary Embolism

A Multicentre, Open Label, Prospective, Comparative Clinical Study to Evaluate the Efficacy and Safety of Heparin Injection 25000 IU Manufactured by Nirma limited (Nirlife Healthcare), India with HEP (Heparin Injection) 25000 IU Manufactured by Gland Pharma Limited, India for Prophylaxis and Treatment as Anticoagulant and Thrombolytic In Deep Vein Thrombosis and Pulmonary Embolism

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/02/003359

Enrollment

120

Registered

2013-02-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: D696- Thrombocytopenia, unspecified

Interventions

Intervention1: Heparin Injection 25000 IU: 5000 IU subcutaneously t.i.d. for 5 to 7 days Control Intervention1: HEP (Hepain Injection) 25000 IU: 5000 IU subcutaneously t.i.d. for 5 to 7 days

Eligibility

Inclusion criteria

Inclusion criteria: Patients with any one of the following condition: •For prevention of clotting in arterial and heart surgery or •For prevention of postoperative deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing major abdomino-thoracic surgery or who for other reasons are at risk of developing thromboembolic disease or •Prophylaxis and treatment of PE or •Prophylaxis and treatment of peripheral arterial embolism

Exclusion criteria

Exclusion criteria: 1. Patients with bleeding disorders and those having brain or spinal cord surgery, spinal anaesthesia, eye surgery, or potentially sanguineous operations. 2. Patient admitted with a primary diagnosis of trauma. 3. Patient admitted to neurosurgery or requires a neurosurgical procedure. 4. Patients having platelets 5. Patients with disorders of hemostasis (INR > 1.40). 6. Patients with renal dysfunction (serum creatinine > 1.50). 7. Patients with deep hyperthermia. 8. Patients with values for serum glutamic pyruvic transaminase (SGPT) or serum glutamic oxaloacetic transaminase (SGOT) >2 times upper limit of normal (ULN). 9. Patients with history of heparin-induced thrombocytopenia. 10. Previous use (15 days before study start) of oral anticoagulants or expected use during the study. 11. Patients on current full anticoagulation medications including a heparin drip or warfarin 12. Use of any antiplatelet drugs (thienopyridine like drugs and aspirin) for less than 5 days. 13. Use of low molecular weight heparin for less than 24 hours or Use of non-fractioned heparin for less than 12 hours.

Design outcomes

Primary

Measure	Time frame
1. Incidence of DVT or PE 2. Mean change in APTT 3. Mean change in INRTimepoint: 5-7 days	—

Secondary

Measure	Time frame
No. of patients with mortality, major bleeding and thrombocytopeniaTimepoint: 5-7 days	—

Countries

India

Contacts

Public ContactDr Hemant Desai

Ethicare Clinical Trial Services

milansatia@ethicare-cro.com09825585119

Outcome results

None listed

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