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

Phase 4

Completed

• Conditions: Health Condition 1: D696- Thrombocytopenia, unspecified

• Registration Number: CTRI/2013/02/003359
• Lead Sponsor: irma Limited Nirlife Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

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

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 < 125,000 mm3.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Incidence of DVT or PE <br/ ><br>2. Mean change in APTT <br/ ><br>3. Mean change in INRTimepoint: 5-7 days

Secondary Outcome Measures

Name	Time	Method
o. of patients with mortality, major bleeding and thrombocytopeniaTimepoint: 5-7 days