Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Lung Neoplasms

Vascular Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Prostatic Neoplasms

Breast Neoplasms

Colorectal Neoplasms

Recurrence

Lymphoma

Leukemia

Thrombosis

Hemostatic Disorders

Blood Coagulation Disorders

Body Weight

Gastrointestinal Neoplasms

Intestinal Neoplasms

Lymphoproliferative Disorders

Myeloproliferative Disorders

Thromboembolism

Venous Thromboembolism

Venous Thrombosis

Urogenital Neoplasms

Digestive System Neoplasms

Lymphatic Diseases

Embolism

Embolism and Thrombosis

Lymphosarcoma

Chronic Myeloproliferative Disorders

Fibrinolytic Agents

Anticoagulants

All Drugs and Chemicals

Coagulants

Heparin

Hemostatics

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Patients with objectively confirmed cancer associated venous thromboembolism receiving tinzaparin treatment to prevent recurrence of venous thromboembolism

Subcutaneous injection of 175 IU/kg once daily for 6 months

G Meyer, Professor

F Scotte, Dr

The purpose of this study is to validate the Ottawa score (risk of thromboembolic recurrences) in cancer patients with thromboembolic disease treated with tinzaparin (Innohep®)

The Ottawa score is a clinical predictive score aiming at stratifying thromboembolic recurrences in cancer patients according to identified clinical risk factors and histological type of the tumor. This score has never been validated externally in a prospective way in patients treated with tinzaparin. The objective of this observational prospective study is to enroll cancer patients with TED treated with tinzaparin for a planned period of 6 months and to collect data on thromboembolic recurrences, major hemorrhages, deaths and heparin-induced thrombocytopenia

Non Interventional Study of the Validation of the Ottawa Score in Cancer Patients With Venous Thromboembolism (VTE)

Prediction of Thromboembolic Recurrences in Cancer Patients With Venous Thromboembolic Disease (TED)

LEO Pharma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Subcutaneous tinzaparin 4,500 IU once daily for six months.

Tinzaparin Sodium

Guy Meyer, MD

Prospective randomized open multicenter trial with blinded adjudication of endpoints to assess the efficacy of six-month low-dose LMWH (Low Molecular Weight Heparin) for the prevention of symptomatic or incidental VTE in patients with stage IV lung cancer and elevated D-dimer.

Adult patients aged ≥ 18 years with stage IV lung cancer and elevated D-dimer will be randomized to the experimental or control group.Patients in the control group will receive usual care, patients in the experimental group will receive subcutaneous tinzaparin once daily for six months. Follow-up visit will take place in outpatient clinic at day 90, day 180 and day 360. Blood sampling for biomarkers will be performed at inclusion visit and day 90.

Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)

Long-term Prophylaxis of Venous Thromboembolism With Low-molecular-weight Heparin in Patients With Metastatic Lung Cancer

All venous thromboembolism (VTE) events during the six-month treatment period including:

* objectively confirmed symptomatic pulmonary embolism (PE),
* objectively confirmed symptomatic lower-limb deep vein thrombosis (DVT) (including iliac and caval thrombosis),
* objectively confirmed symptomatic upper extremity DVT,
* objectively confirmed incidentally diagnosed PE or proximal DVT
* death due to PE.

Objectively confirmed symptomatic VTE and death due to PE

Objectively confirmed symptomatic or incidental VTE during the 12-months study period

Major bleeding according to the ISTH criteria

Ministry of Health, France

National Cancer Institute, France

Assistance Publique - Hôpitaux de Paris

Pulmonary Embolism

Herbal and Botanical

Cola

The treatment arm will receive a subcutaneous injection of tinzaparin (4500U) daily beginning within two days of the decision to operate (within 6 weeks of surgical resection) weeks and continued for 4 weeks following resection.

The control arm will receive a subcutaneous injection of 4,500 U of tinzaparin daily beginning with the first postoperative dose and continued for the duration of hospitalization.

Marc Carrier, MD MSc

Rebecca Auer, MD MSc

Tim Asmis, MD

The blood thinner "tinzaparin" might increase survival in patients with colon cancer undergoing surgical resection. The investigators want to assess if a trial allocating patients to prolonged treatment with tinzaparin versus standard of care is feasible.

Cancer patients are at high risk of postoperative thrombosis and this risk remains elevated beyond the period of hospitalization. Thromboprophylaxis effectively reduces the risk of post operative VTE in cancer patients. Extended thromboprophylaxis beyond hospitalization (up to 30 days) with LMWH has been shown to further reduce the risk of postoperative VTE. Concurrently, there is a growing body of evidence to suggest that LMWH may have anti-cancer effects due to anti-metastatic properties and may improve survival in cancer patients, even in the absence of a documented VTE. Retrospective studies have shown that perioperative thromboprophylaxis (i.e., starting thromboprophylaxis before the surgery) seems to increase survival in cancer patients undergoing abdominal or pelvic cancer surgery with curative intent. The investigators propose to perform an open-label RCT to determine if thromboprophylaxis using tinzaparin 4,500 IU daily, starting from the time of decision to operate through the peri-operative period and extending for 4 weeks postoperatively, is feasible.

Thromboprophylaxis for Patients Undergoing Surgical Resection for Colon Cancer

The Use of Extended Perioperative Low Molecular Weight Heparin to Improve Cancer Specific Survival Following Surgical Resection of Colon Cancer: A Pilot Randomized Controlled Trial

Ottawa Hospital Research Institute

Anti-Infective Agents

Amino Acids

Dabigatran

Antithrombins

Antithrombin III

Protease Inhibitors

Serine Proteinase Inhibitors

HIV Protease Inhibitors

Enzyme Inhibitors

Serine

Tinzaparin 175 iu/kg daily will be started after the diagnosis of VTE is confirmed dabigatran 150mg twice daily from Day 6 onward till 6 months after underlying disease remission.

Dabigatran etexilate

Tinzaparin 175 iu/kg daily will be started after the diagnosis of VTE is confirmed

Gloria Hwang, MBBS

Crosby Lu, MMedSc

This trial aims at determining if dabigatran is effective in the treatment of malignancy associated VTE. Tolerance and safety of dabigatran will also be assessed.

This is a single armed trial of dabigatran in patients with malignancy associated VTE.

The target recruitment is 99 consecutive patients with active malignancy and newly diagnosed VTE (deep vein thrombosis and/or pulmonary embolism) in Queen Mary Hospital.

Tinzaparin 175 iu/kg daily will be started after the diagnosis of VTE is confirmed (duplex Doppler ultrasonography for deep vein thrombosis, and computed tomography for pulmonary embolism), and a written consent is obtained. Patients will be switched to dabigatran 150mg twice daily from day 6 onwards. The first dose of dabigatran will be given within 2 hours before the time that the next dose of tinzaparin would have been due. Anticoagulation will be continued as long as malignancy is active. If patients achieve a complete remission of their underlying malignancies, dabigatran will be continued for 6 months further.

Patients with malignancies are at increased risks of venous thromboembolism (VTE). The annual incidence of VTE in cancer patients is 0.5%, which is 5-fold more than the general population . Low molecular weight heparin (LMWH) has been the standard treatment for malignancy-associated VTE. This recommendation follows the results of the Randomized Comparison of Low-Molecular-Weight Heparin versus Oral Anticoagulant Therapy for the Prevention of Recurrent VenousThromboembolism in Patients with Cancer (CLOT) trial, which showed superiority of Low molecular weight heparin (LMWH) over warfarin in cancer patients with VTE .

Low molecular weight heparin (LMWH) has a number of inherent advantages over warfarin. It does not interact with chemotherapeutic agents, and dose titration is not necessary. Furthermore, the risks of both bleeding and breakthrough VTE are also lower with LMWH. However, the requirement of daily subcutaneous injection makes LWMH inconvenient to use. Most patients have difficulties continuing daily injection, partly owing to compliance issues, but also because an emaciated state in some patients makes subcutaneous injection painful. As the life expectancy of solid cancer patients is improved with novel treatment options, the choice of anticoagulation has become a major issue in the management of VTE in this patient population.

The main reason underlying the inferior performance of warfarin in oncology patients is difficult dose titration. Drug interaction and hepatic dysfunction are common in patients on chemotherapy. Frequent interruptions of warfarin for invasive procedures and chemotherapy-induced-thrombocytopenia also lead to fluctuations in anticoagulation level. As a result, highs risk of recurrence of VTE and bleeding were observed in cancer patients taking warfarin. Direct-acting oral anticoagulants (DOACs), on the other hand, may be an attractive alternative treatment to LMWH. They are administered at a fixed dose with predictable pharmacokinetics, so that therapeutic monitoring is not required. There is minimal food and drug interaction. They have been shown to be effective in the treatment of VTE in several pivotal randomized controlled trials in comparison with warfarin . However, their role in malignancy associated VTE is yet to be determined, because cancer patients were either excluded or very much underrepresented in these VTE treatment trials. Moreover, the non-inferiority of DOACs in VTE treatment was only demonstrated against warfarin, which is already shown to be suboptimal in oncology patients. A trial directly comparing DOACs with LMWH in malignancy associated VTE is therefore needed.

Dabigatran etexilate is an oral thrombin inhibitor. It was shown in the RECOVER study to be effective in treatment of VTE and it has a lower bleeding risk than warfarin. It is not metabolized by cytochrome P450 system and therefore, in contrast to other DOACs, concomitant administration of CYP3A4 inducers or inhibitors is not a concern.

We propose this prospective single armed trial to evaluate the efficacy and safety of dabigatran in the treatment of malignancy associated VTE. We will compare the result with our historical control who were treated with LMWH.

A Study of Dabigatran Etexilate as Primary Treatment of Malignancy Associated Venous Thromboembolism

A Prospective Study of Dabigatran Etexilate as Primary Treatment of Malignancy Associated Venous Thromboembolism

first episode of objectively documented symptomatic recurrent VTE (deep vein thrombosis, pulmonary embolism)

The University of Hong Kong

Clinical Professor

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Pharmaceutical Solutions

Drug: Tinzaparin (Innohep®), solution for injection. Administration form: Subcutaneous injection. Dosage: 4500 IU (for subjects weighing below 90 kg) or 8000 IU (for subjects weighing 90 kg and above) daily for 21-28 weeks.

Tinzaparin Injectable Solution

Preben Kjölhede, MD, PhD

Anna Karlsson, MD

Malena Tiefenthal Thrane, MD

Catarina Notelid Claus, MD

Hanna Reimerson, MD

Karin Bergmark, MD, PhD

Pernilla Dahm-Kähler, MD, PhD

Boglarka Fekete, MD

Laila Falknäs, MD

Christiane Sackbrook, MD

Anke Zbikowski, MD

Narmin Rasul, MD

Gabriel Lindahl, MD, PhD

Annika Holmquist, MD, PhD

Oscar Derke, MD

Ulrica Beiron, MD

Tommy Leijon, MD

Ulrika Ottander, MD, PhD

Charlotte Öfverman, MD, PhD

Pernilla Israelsson, MD, PhD

Shefqet Halili, MD

Anders Rosenmüller, MD

Helena Avenström, MD

Anna-Clara Spetz Holm, MD, PhD

Background:

Previous findings have indicated antineoplastic properties of tinzaparin (Innohep®), a commonly used anti-coagulant. Earlier studies have mainly investigated the antineoplastic effects of tinzaparin in animal models and in human cell-lines. In this pilot study the aim is to examine the potential antitumoral effects of tinzaparin in vivo in women with epithelial ovarian cancer (EOC).

Study objectives:

Primary objective: The primary objective of the study is to evaluate the effects of tinzaparin on changes in levels of CA-125 in EOC patients who receive neoadjuvant chemotherapy (NACT).

Secondary objectives: The secondary objective of the study is to explore the impact of tinzaparin on the dynamic of a spectrum of immunological and coagulation factors in EOC patients who receive NACT. Besides, the compliance of tinzaparin injections and adverse events caused by tinzaparin will be described.

This is an open randomized controlled clinical pilot trial (Phase II). The study includes women with the International Federation of Obstetrics and Gynecology (FIGO) stage III-IV EOC selected for neoadjuvant chemotherapy (NACT) and without signs of thromboembolic disease or ongoing treatment of thromboembolic disease. The women will be allocated 1:1 to treatment with tinzaparin 4500 IU/8000 IU (dose depending on woman's weight) subcutaneously once daily or no tinzaparin. The treatment group starts tinzaparin when the primary treatment (chemotherapy) starts. The control group will not receive tinzaparin or other low molecular weight heparin preparations. The NACT consists of carboplatin and paclitaxel, given according to the standard regimen with cycle repeats every 21 days. Pre-treatment, before every cycle of chemotherapy, before delayed primary debulking surgery (DPDS) and three weeks after the last cycle of chemotherapy venous blood samples will be taken for measuring the biomarkers hemoglobin, platelets, leucocytes, C-reactive protein (CRP), albumin, cancer antigen-125 (CA-125), Tissue Factor, D-dimer, soluble P-selectin, thrombin-antithrombin complex and thrombin generation potential. Furthermore, a panel of 92 inflammation-associated proteins will be analyzed by a by a high-sensitivity Proximity Extension Assay at baseline, visit 5 and visit 8 or 9. After three cycles of NACT, the patient will be evaluated clinically and with imaging diagnostics in order to determine whether the patient should undergo DPDS. In the investigators´ setting, \> 80% of patients receiving NACT for EOC undergo DPDS. After DPDS, all patients will be treated with tinzaparin for 28 days according to clinical practice concerning postoperative thromboembolic prophylaxis and thereafter continue the chemotherapy for additional two-three courses. The participants who were allocated to tinzaparin during the NACT will continue the tinzaparin after ending the postoperative thromboembolic prophylactic tinzaparin treatment for additional 2-3 courses. The biomarkers will be measured preoperatively and four weeks postoperatively after DPDS and then before each course of chemotherapy given during the primary treatment. The women who do not undergo surgery will remain included in the study for the following three cycles of chemotherapy. Thus, the total study period constitutes 22-29 weeks.

Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer

The Effect of Tinzaparin on Biomarkers in FIGO Stage III-IV Ovarian Cancer Patients Undergoing Neoadjuvant Chemotherapy - A Randomized Pilot Study

endogenous thrombin generation potential (nmolar\*min)

All 92 inflammation associated proteins are measured in pg/mL

Proportion constitutes the relative number in the group in percent

Region Jönköping County

Västervik Hospital

Vastra Gotaland Region

Region Västerbotten

University Hospital, Linkoeping

Professor, senior consultant

Thrombocytopenia

Blood Platelet Disorders

Hematologic Diseases

Cytopenia

Enoxaparin

Enoxaparin sodium

Patients will be given modified dose LMWH as below based on the first platelet count of the day (daily in admitted patients or at least 2 times a week in outpatients), without empiric platelet transfusion:

I. Platelet count 25-50,000/µL: 50% dose LMWH

II. Platelet count \< 25,000/µL: hold anticoagulation

Patients assigned to higher dose LMWH (see below) will be given transfusion for 14 days when the first platelet count of the day falls below 50,000/uL (daily inpatient or at least 2 times a week in outpatients). Post-transfusion counts will not be routinely obtained unless clinically indicated

I. Platelet count 25-50,000/µL: platelet transfusion + 100% dose LMWH

II. Platelet count \< 25,000/µL: platelet transfusion + 50% dose LMWH

After Day 14, patients will be transitioned to modified dose LMWH as the other arm without platelet transfusion.

LMWH can include enoxaparin, dalteparin, or tinzaparin, with 100% as:

* Enoxaparin - 1mg/kg subcutaneously twice daily
* Dalteparin - 200 IU/kg subcutaneously daily for 1 month then 150 U/kg daily
* Tinzaparin - 175 units/kg subcutaneously daily

I. Platelet count 25-50,000/µL: 0.5mg/kg subcutaneously twice daily

II. Platelet count \< 25,000/µL: hold anticoagulation

I. Platelet count 25-50,000/µL: 100 IU/kg subcutaneously daily for the first month of an acute VTE then 75 U/kg

II. Platelet count \< 25,000/µL: hold anticoagulation

I. Platelet count 25-50,000/µL: 87.5 units/kg subcutaneously daily

II. Platelet count \< 25,000/µL: hold anticoagulation

Jennifer Brinkhurst

Cynthia Wu, MD

Jennifer Multicentre Trial Coordinator

Tzu-Fei Wang, MD

Andrea Cervi, MD

Marc Carrier, MD

Patients with cancer are prone to have blood clots, which are usually treated with blood thinners. The main complication of blood thinners is bleeding. This is especially a concern when the number of platelets in the blood is lower than 50,000 per microliter. The role of platelets is to stop bleeding, so when the number of platelets is low, patients are at a higher risk of bleeding. Cancer patients are prone to have lower platelet numbers due to cancer therapies and/or cancer itself. It is not clear what the best treatment is for cancer patients who need blood thinners for a blood clot but have low platelet counts.

The investigators plan to do a small study called a pilot study to help plan for a larger study in such patients. In the pilot study, investigators will include 50 patients with cancer, low platelet counts, and a blood clot diagnosed within 4 weeks. Patients will be randomly assigned to one of the two treatment strategies: the full dose of blood thinners along with platelet transfusion or a reduced dose of blood thinners without platelet transfusion. The investigators will follow all patients for 90 days. If this pilot study is successful, it will help lead to a much larger trial, which will provide important information on the best treatment strategy in these patients.

The current proposal is for the pilot trial to assess feasibility of a full-scale RCT. To determine feasibility, the pilot and the full-scale trials will use the same recruitment strategy, inclusion/exclusion criteria, interventions, follow up duration, and measurement/adjudication of clinical outcomes. If the pilot trial finds that the full-scale trial is feasible, and no changes to the study design are indicated, the data from the pilot trial will be included in the full-scale trial, which will be efficient and reduce the recruitment time and costs of the full-scale trial.

The START trial is a multi-centre RCT with prospective, open-label, blind-evaluator (PROBE) design. Adult patients with acute cancer-associated thrombosis (diagnosed within 14 days) and thrombocytopenia (platelet count \< 50,000/µL) secondary to cancer therapy or cancer itself will be randomized 1:1 to modified dose LMWH or higher dose LMWH with platelet transfusion support, to evaluate the superiority of a modified dose LMWH strategy in reducing clinically relevant bleeding events compared to full dose LMWH with platelet transfusion. The PROBE design is an efficient use of research funds while maintaining the benefits of randomization and blinded evaluation of endpoints.

STrategies for Anticoagulation in Patients With thRombocytopenia and Cancer-associated Thrombosis

The average number of patients recruited per month

Number of consenting participants from the number of eligible patients

Reasons for non-participation in eligible patients

Number of participants adhering to the protocol (such as anticoagulation, transfusion, platelet count monitoring according to the protocol)

Number of participants withdrawing from study

Number of participants crossing over between treatment arms

Rate of clinically relevant bleeding (composite of major bleeding and clinically relevant non-major bleeding events)

Rate of symptomatic or incidentally detected recurrent or new major VTE

Composite of recurrent VTE and major bleeding events

Number of non-major VTE (distal upper or lower extremity DVT, superficial upper or lower extremity vein thrombosis)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Non Interventional Study of the Validation of the Ottawa Score in Cancer Patients With Venous Thromboembolism (VTE)	NCT03099031	Venous Thromboe...	Tinzaparin	18 Years -	LEO Pharma
Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)	NCT03090880	Venous Thromboe... Lung Neoplasm	Tinzaparin Sodi...	18 Years -	Assistance Publique - Hôpitaux de Paris
Thromboprophylaxis for Patients Undergoing Surgical Resection for Colon Cancer	NCT00967148	Deep Vein Throm... Pulmonary Embol... Cancer	Tinzaparin	18 Years -	Ottawa Hospital Research Institute
A Study of Dabigatran Etexilate as Primary Treatment of Malignancy Associated Venous Thromboembolism	NCT03240120	Venous Thromboe... Deep Vein Throm... Pulmonary Embol...	Dabigatran etex... Tinzaparin	18 Years -	The University of Hong Kong
Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer	NCT05284552	Epithelial Ovar...	Tinzaparin Inje...	18 Years -	University Hospital, Linkoeping
STrategies for Anticoagulation in Patients With thRombocytopenia and Cancer-associated Thrombosis	NCT05255003	Cancer-associat... Thrombocytopeni...	Enoxaparin Dalteparin Tinzaparin	18 Years -	Ottawa Hospital Research Institute
TINzaparin Prophylaxis in Patients With Metastatic Colorectal Cancer	NCT05625932	Colorectal Canc... Thromboembolism	Tinzaparin	18 Years -	Galician Research Group on Digestive Tumors
STrategies for Anticoagulation in Patients With thRombocytopenia and Cancer-associated Thrombosis	NCT05255003	Cancer-associat... Thrombocytopeni...	Enoxaparin Dalteparin Tinzaparin	18 Years -	Ottawa Hospital Research Institute
Thromboprophylaxis for Patients Undergoing Surgical Resection for Colon Cancer	NCT00967148	Deep Vein Throm... Pulmonary Embol... Cancer	Tinzaparin	18 Years -	Ottawa Hospital Research Institute
Extended Peri-operative Tinzaparin to Improve Disease-free Survival in Patients With Resectable Colorectal Cancer	NCT01455831	Adenocarcinoma ...	Tinzaparin Tinzaparin	18 Years -	Ottawa Hospital Research Institute
Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)	NCT03090880	Venous Thromboe... Lung Neoplasm	Tinzaparin Sodi...	18 Years -	Assistance Publique - Hôpitaux de Paris

Spots Global Cancer Trial Database for tinzaparin

Every month we try and update this database with for tinzaparin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tinzaparin

Every month we try and update this database with for tinzaparin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tinzaparin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.