Anticoagulation Length in Cancer Associated Thrombosis

Phase 1

• Conditions: Cancer Associated Thrombosis (CAT). Venous thromboembolism (VTE). Deep vein thrombosis (DVT). Pulmonary embolus (PE).; MedDRA version: 14.1 Level: LLT Classification code 10049910 Term: Thromboembolism prophylaxis System Organ Class: 100000004865; MedDRA version: 14.1 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis System Organ Class: 100000004865; MedDRA version: 14.1 Level: LLT Classification code 10066899 Term: Venous thromboembolism System Organ Class: 100000004866; MedDRA version: 14.1 Level: LLT Classification code 10013880 Term: DVT prophylaxis System Organ Class: 100000004865; MedDRA version: 14.1 Level: LLT Classification code 10037380 Term: Pulmonary embolus System Organ Class: 100000004855; MedDRA version: 14.1 Level: LLT Classification code 10037436 Term: Pulmonary thromboembolism System Organ Class: 100000004855; MedDRA version: 14.1 Level: LLT Classification code 10043566 Term: Thromboembolism System Organ Class: 100000004866; MedDRA version: 14.1 Level: LLT Classification code 10013877 Term: DVT System Organ Class: 100000004866; MedDRA version: 14.1 Level: LLT Classification code 10013878 Te

• Registration Number: EUCTR2012-004117-14-GB
• Lead Sponsor: Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-14
• Study Completion: 2014-11-22
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

1. Receiving LMWH for treatment of CAT for five months; 2. Locally advanced or metastatic cancer; 3. Able to self-administer LMWH, or have LMWH administered by a carer; 4. Able to give informed consent; 5. Age =16 years.
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1.Receiving drug other than LMWH for CAT; 2.Contraindication to anticoagulation; a. known allergies to LMWHs, heparin, sulfites or benzyl alcohol, b. active major bleeding c. history of heparin-induced thrombocytopenia 3. Confirmed recurrent VTE whilst receiving anticoagulation; 4. Fitted with a prosthetic heart valve; 5. Pregnant and/or lactating females.

Study & Design

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