Clinical Trials Logo

Clinical Trial Summary

The purpose of the study is to examine the efficacy and safety of prolonged thromboprophylactic treatment with Fragmin® in oesophageal cancer patients undergoing intended curative surgery.

Clinical Trial Description

Hypotheses 1. The intervention group of oesophageal cancer patients, who receive prolonged thromboprophylaxis with Fragmin® has a lower VTE risk, expressed by a lower prothrombin fragment F1+2, 30 days after surgery than the control group, who receive Fragmin® for 10 days. 2. The intervention group does not demonstrate an increased bleeding tendency compared with the control group. Primary endpoint The primary endpoint is the difference in prothrombin fragment F1+2 30 days after surgery between the intervention and the control group. Secondary and safety endpoints The secondary endpoints are incidence of bleeding, VTE and mortality 30 days and one year after surgery. Study design The study is comprised of three specific objectives, presented in three work packages (WP): - WP1: Randomization of 100 oesophageal cancer patients undergoing intended curative surgery to either a 10 or 30-day prophylactic LMWH-regime. - WP2: Investigation of the coagulation in the WP1 population. The aim is to substantially improve understanding of the coagulation pathophysiology and the mechanisms behind the increased thromboembolic risk in oesophageal cancer patients. - WP3: The lectin pathway complement proteins are suspected to play a role in the increased risk of thrombosis in cancer. We aim to examine this further by measuring complement protein levels in the WP1 population and investigate if there is a correlation between complement levels and changes in the coagulation. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05067153
Study type Interventional
Source University of Aarhus
Contact Anne-Mette Hvas, MD
Phone 004578455252
Email [email protected]
Status Recruiting
Phase Phase 4
Start date May 1, 2021
Completion date May 1, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT03826043 - THrombo-Embolic Event in Onco-hematology N/A
Enrolling by invitation NCT04398628 - ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
Recruiting NCT02972385 - Pharmacogenomics of Warfarin in Hispanics and Latinos
Active, not recruiting NCT02917213 - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed NCT02526628 - Thrombosis and Neurocognition in Klinefelter Syndrome
Completed NCT02439190 - CV004-007 Thrombosis Chamber Study Phase 1
Completed NCT02341638 - Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects Phase 1
Completed NCT01855516 - Partial Thromboplastin Time After 72 Hours of Antithrombotic Prophylaxis Using Unfractionated Heparin N/A
Unknown status NCT00983112 - Evicel Study on the Peri-operative Bleeding in Total Knee Prothesis Surgery Phase 4
Completed NCT00412464 - Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis Phase 1
Completed NCT00479362 - Anticoagulant Therapy During Pacemaker Implantation Phase 4
Completed NCT00346424 - Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters Phase 3
Terminated NCT00303420 - Alteplase for Blood Flow Restoration in Hemodialysis Catheters Phase 4
Completed NCT00143715 - Oral Vitamin K for Warfarin Associated Coagulopathy Phase 3
Completed NCT00039858 - Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin Phase 4
Completed NCT00007410 - Genetic Architecture of Plasma T-PA and PAI-1 N/A
Completed NCT00000538 - Dietary Effects on Lipoproteins and Thrombogenic Activity (DELTA) Phase 3
Completed NCT00005436 - Lupus Cohort--Thrombotic Events and Coronary Artery Disease N/A
Completed NCT00000466 - Postmenopausal Estrogen/Progestin Interventions (PEPI) Phase 3
Recruiting NCT04517461 - Coagulation and Vitamin K in Head and Neck Microvascular Free Flap Surgery