Biochemical Analysis of Heparins for Injection versus Heparins for Infusion as Prevention of Thrombosis after Bypass Operations

Phase 1

• Conditions: Deep venous thrombosis, myocardial infarction, cerebral infarction, bleeding; MedDRA version: 19.0Level: PTClassification code 10062354Term: Ischaemic heart disease prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 19.0Level: LLTClassification code 10023024Term: Ischaemic heart diseaseSystem Organ Class: 100000004849; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2015-000702-19-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-13
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients admitted for elective CABG operation at the Thoracical Surgery Deparment at Rigshospitalet.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

Age < 18 years, reoperations, acute operations (<24 timer), lack of pausation of trombcyte inhibitors 4 days prior to operation, requirement for another trombocyteinhibitor than ASA, weight under 60 kg or above 100 kg, lack of informed conset, treatment with vitamin-K antagonist or NOAC, liver insufficiency, kidney insufficiency, gout, pregnancy, treatment with other anticoagulants, participation in another study, allergy to the IMPs, haemorrhagic diathesis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified