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Fibrin fragment D

Patients randomized to this arm will be evaluated according to the YEARS algorithm.

Patients randomized to this arm will undergo a contrast enhanced CTPA.

Patients randomized to the YEARS algorithm will be evaluated according to the YEARS algorithm consisting of three items of the original Wells rule (clinical signs of DVT, haemoptysis and 'PE most likely diagnosis') and a D-dimer test. In patients without any of the three items and a D-dimer level \<1.0 μg/mL (\<1000ng/mL), and in patients with ≥1 items and a D-dimer level \<0.5 μg/mL (\<500 ng/mL) a PE is excluded without CTPA. In the other patients a standard contrast enhanced CTPA will be performed according to local practice. PE is defined as at least one filling defect in the pulmonary artery tree on CTPA.

YEARS algorithm

Patients randomized to the CTPA management group will undergo a contrast enhanced CTPA to rule out PE according to standard local practice.

CTPA

Emily MARTENS, MD

Menno HUISMAN, Pr

Jo RASKIN, Dr

Andrea PENALOZA, Pr

Alexandre GHUYSEN, Pr

Francis COUTURAUD, Pr

Jeannot SCHMIDT, Pr

Isabelle MAHE, Pr

Olivier SANCHEZ, Pr

Laurent BERTOLETTI, Dr

Giorgio COSTANTINO, Pr

Roberto POLA, Dr

Marije ten WOLDE, Dr

Michiel COPPENS, Dr

Marcel HOVENS, Dr

Marco GROOTENBOERS, Dr

Rolf BROUWER, Dr

Yordi VAN DOOREN

Pieter Willem KAMPHUISEN, Pr

Jenneke LEENTJENS, Dr

Reinier Albert SPRENGER

Mariëlle DE VREEDE

Martje MAAS

René VAN DER GRIEND, Dr

David Jiménez, Pr

Tobias TRITSCHLER, Dr

Marc RIGHINI, Pr

Olivier HUGLI, Dr

The aim of this study is to prospectively validate the safety and efficiency of management according to the YEARS algorithm to safely rule out clinically suspected PE in patients with active malignancy to be compared with 'standard' management by computed tomography pulmonary angiography (CTPA) alone in a randomized study.

Recently, the YEARS-algorithm was demonstrated to be a safe and efficient diagnostic strategy for patients with clinically suspected pulmonary embolism (PE). It is recognized that diagnostic algorithms for pulmonary embolism (PE) may not be as effective and safe in patients with malignancy, due to the low specificity of D-dimer test in that setting. A diagnostic algorithm that could safely rule out PE in patients with malignancy without performing computed tomography pulmonary angiography (CTPA) could nonetheless improve patient care.

Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy

Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy : HYDRA Study

All collected data that underlie results in a publication

Number of performed CTPA will be observed in the YEARS-group at baseline

Leiden University Medical Center

Insel Gruppe AG, University Hospital Bern

University Hospital, Antwerp

University Hospital, Brest

Symptoms and General Pathology

Body Weight

Venous Thrombosis

Fibrinolytic Agents

Anticoagulants

Heparin

Warfarin

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Michael J Kovacs, MD, FRCPC

The purpose of this study is to obtain an estimate of catheter survival in the setting of upper extremity deep vein thrombosis (UEDVT) in patients treated with dalteparin and warfarin.

Anticoagulation with dalteparin and warfarin in patients with UEDVT secondary to central venous catheters in patients with an active malignancy is an effective therapy as quantified by the success of catheter preservation. A prolonged line salvage rate without a recurrence of UEDVT will improve the management of cancer patients who develop upper extremity deep venous thrombosis in the setting of a central venous (CV) catheter.

Deep venous thrombosis (DVT) is a serious disorder with an annual incidence of approximately 0.1% and increasing with age to 1% in the elderly. Deep venous thrombosis of the upper extremity (UEDVT) is estimated to constitute 1-5% of all cases of DVT.

The therapy of UEDVT has not been standardized.Therapeutic options include anticoagulation with unfractionated heparin followed by warfarin, treatment with a thrombolytic agent, or a thrombectomy. Recently, treatment with low molecular weight heparin has been shown to be a safe and effective treatment for patients with verified UEDVT.

In patients with cancer, treatment of UEDVT associated with central venous catheters is even less standardized. Some groups advocate removal of the catheter as the sole treatment for the DVT, others remove the catheter and treat the DVT. A major disadvantage to removing the line is that often re-insertion in the opposite limb is then required to avoid disruption of chemotherapeutic treatment. This reinsertion again puts the patient at risk for thrombosis and pulmonary embolism. Another therapy is treatment only with systemic thrombolytic therapy. The disadvantage of thrombolytic therapy in persons with cancer is that there is a high risk for major bleeding at the doses used.

A treatment regimen that has been adopted by the London Health Sciences Centre, and others across Canada, is to leave the catheter in place and treat the DVT with low molecular weight heparin and warfarin. This regimen is believed to halt the progression of thrombi, prevent embolism and allow natural thrombolytic mechanisms to work effectively. By leaving the central line in situ and appropriately treating the thrombosis there is no disruption in the delivery of life-prolonging or life-saving treatment in the form of chemotherapy.

Preliminary data has been collected over the past 24 months at the London Health Sciences Centre; the results suggest that this approach to treatment will prove to be beneficial to the patient. Thirteen (13) patients with cancer and an UEDVT associated with a central venous catheter were treated with dalteparin and warfarin with an intention to leave the central line in situ. Of the 13, 1 patient had the line removed after 3 days at a peripheral hospital against recommendation. The UEDVT was treated successfully and without the need for line removal in 9 (75%) of the remaining 12 patients. Two (2) of the 12 had lines removed at 1 week and 1 had the line removed at 4 weeks due to worsening symptoms of UEDVT.

Therefore, UEDVT is a more common and less benign disease than previously reported and generally arises in the presence of recognizable risk factors such as central venous catheters and cancer. Treatment of the UEDVT with dalteparin and warfarin will treat the thrombosis while preserving the central venous access for continued use. Hence, the need for additional catheters and subsequent risk of bilateral UEDVT will be minimized.

Result of the CLOT (Clot in Cancer) Trial have shown the superiority of treatment with dalteparin for 6 months as compared to the conventional treatment with short-term dalteparin and extended warfarin for cancer patients with acute symptomatic DVT or PE. Extended anticoagulant therapy may be beneficial in patients with UEDVT as well, however, there are currently no estimates of clinical outcomes for either conventional (dalteparin followed by warfarin) or extended therapy with dalteparin in this patient population.

The Catheter Study: Central Venous Catheter Survival in Cancer Patients Using Low Molecular Weight Heparin (Dalteparin) for the Treatment of Deep Vein Thrombosis

A Pilot Study of Central Venous Catheter Survival in Cancer Patients Using Low Molecular Weight Heparin (Dalteparin) for the Treatment of Deep Vein Thrombosis of the Upper Extremity

Pfizer

Lawson Health Research Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy	NCT04657120	Pulmonary Embol... Embolism Embolism and Th... Vascular Diseas... Cardiovascular ... Lung Diseases Respiratory Tra... Cancer Diagnosis	YEARS algorithm CTPA	18 Years -	University Hospital, Brest
The Catheter Study: Central Venous Catheter Survival in Cancer Patients Using Low Molecular Weight Heparin (Dalteparin) for the Treatment of Deep Vein Thrombosis	NCT00216866	Embolism and Th...	Dalteparin Warfarin	18 Years -	Lawson Health Research Institute
The Catheter Study: Central Venous Catheter Survival in Cancer Patients Using Low Molecular Weight Heparin (Dalteparin) for the Treatment of Deep Vein Thrombosis	NCT00216866	Embolism and Th...	Dalteparin Warfarin	18 Years -	Lawson Health Research Institute

Spots Global Cancer Trial Database for embolism and thrombosis