Symptoms and General Pathology

All Conditions

Heart and Blood Diseases

Digestive System Diseases

Ulcer

Thrombosis

Crohn Disease

Colitis

Colitis, Ulcerative

Thromboembolism

Venous Thromboembolism

Venous Thrombosis

Diverticulum

Diverticular Diseases

Gastrointestinal Diseases

Intestinal Diseases

Inflammatory Bowel Diseases

Gastroenteritis

Embolism

Embolism and Thrombosis

Vascular Diseases

Pathological Conditions, Anatomical

Coagulants

All Drugs and Chemicals

Anticoagulants

Fibrin fragment D

Fibrin Fibrinogen Degradation Products

Antifibrinolytic Agents

Hemostatics

Subjects who meet the inclusion criteria that will have colorectal surgery at UTMB

D-dimer blood test- The D-dimer assay detects the presence of fibrin degradation products, which can indicate the breakdown of a fibrin clot Lower Limb Venous Duplex- Using an ultrasound to visually look for a clot

D-dimer and lower limb venous duplex

Uma Phatak, MD

The purpose of this study is to evaluate the use of a D-dimer based protocol to screen for thrombotic events in colorectal surgical patients. This study is unique because of the multistage screening process for DVT's using a standardized D-dimer testing methodology and ultrasound that will take place throughout the preoperative, perioperative, and postoperative processes. The data collected from this screening study will help establish the baseline DVT rates in UTMB's colorectal surgical patients before and after surgery. Additionally, the data from this study can help determine if a D-dimer blood test has predictive value in UTMB's colorectal surgical patient population. This study may also provide preliminary evidence for further research regarding the adjustment of D-dimer cutoff values. Specifically for patient subsets such as surgical colorectal patients with a moderate pretest probability and clinical conditions associated with low test specificity

This will be a quantitative prospective cohort study conducted at the University of Texas Medical Branch (UTMB) Galveston and League City campuses. Candidates include subjects who will have elective colorectal surgery at UTMB. This study looks to enroll 100 subjects who meet inclusion criteria. The subjects will undergo screening for DVT using a lower limb bilateral venous duplex and a plasma D-dimer assay no longer than 10 days before their operation. This data will be used to observe the point prevalence of DVT's in preoperative colorectal subjects prior to having colorectal surgery. On the day of surgery, the subject will have a D-dimer test. After the operation, for next 2 days the subjects will have a daily D-dimer test and a lower limb bilateral venous duplex on the second day only. This data will determine the incidence of DVT's that were detected by lower limb bilateral venous duplex on inpatient stay day 2 and possibly indicated by an upward trending D-dimer value during the first 2 days of the inpatient stay. Approximately 2 weeks after surgery, at the postoperative clinic appointment, the subject will have a D-dimer assay and a lower limb bilateral venous duplex. This information will be used to determine the number of DVT events in postoperative colorectal hospitalized subjects that were on the D-dimer monitoring protocol. The D-dimer assay detects the presence of fibrin degradation products, which may indicate a fibrin blood clot in the body.6 A maximum of 5 milliliters of blood will be collected for each D-dimer test. If a DVT is detected by the gold standard method which is a bilateral lower limb duplex during any point of study, the subject will be treated as per standard of care at UTMB by the colorectal surgical team

The Correlation of a D-dimer Testing Protocol With Venous Thromboembolism in Surgical Colorectal Patients

The data will be used to discover the prevalence of DVT prior to surgery and to establish DVT baseline rates at UTMB.

Subjects will have a venous duplex on day two after surgery to look for a DVT

The data will be used to determine the number of DVT's that were discovered in the subject population and to establish baseline rates of DVT after surgery and hospital discharge

This data will be used to compare the D-dimer values in subjects that had DVT prior to surgery to those who developed a postoperative DVT while inpatient or at the postoperative clinic appointment

These results will be used as preliminary evidence for future research to determine if revised D-dimer cut off values can be diagnostic in conditions known to have low test specificity

The University of Texas Medical Branch, Galveston

Neoplasms

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Pancreatic Neoplasms

Pulmonary Embolism

Lung Diseases

Respiratory Tract Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Anti-Infective Agents

Amino Acids

Edoxaban

Apixaban

Factor Xa Inhibitors

Antithrombins

Antithrombin III

Protease Inhibitors

Serine Proteinase Inhibitors

HIV Protease Inhibitors

Enzyme Inhibitors

Serine

Subjects to receive single dose of apixaban

Apixaban is an orally administered highly selective factor Xa inhibitor, belonging to the class of direct-acting oral anticoagulants (DOAC) along with rivaroxoban and edoxaban. Factor Xa is an essential mediator of the clotting pathway in humans. Apixaban is currently approved by the FDA for treatment of VTE, prophylaxis of DVT in patients undergoing knee and hip replacement surgeries and for reducing the risk of embolic stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Walter K Kraft, MD

Study investigators will examine the absorption characteristics of apixaban, a direct-acting oral anticoagulation, in patients who have underwent a particular kind of surgery (pancreaticoduodenectomy) which involves resection of the duodenum.

This study will examine apixaban pharmacokinetic exposure (AUC(0-24)) and maximum concentration (Cmax) when administered as a single oral dose in patients who have undergone pancreaticoduodenectomy (PD) compared to historical controls. This is a phase one, single dose pharmacokinetic study in stable patients who have undergone pancreaticoduodenectomy. Apixaban is an orally administered highly selective factor Xa inhibitor, belonging to the class of direct-acting oral anticoagulants (DOAC) along with rivaroxoban and edoxaban. Factor Xa is an essential mediator of the clotting pathway in humans. Apixaban is currently approved by the FDA for treatment of VTE, prophylaxis of DVT in patients undergoing knee and hip replacement surgeries and for reducing the risk of embolic stroke and systemic embolism in patients with nonvalvular atrial fibrillation. This study aims to compare the pharmacokinetics and absorption of oral apixaban in patients who have undergone pancreaticoduodenectomy to that of apixaban in historical controls.

Pharmacokinetics of Apixaban in Patients Undergoing Pancreaticoduodenectomy

An Exploratory Study of the Pharmacokinetics of Apixaban in Patients Undergoing Pancreaticoduodenectomy

Thomas Jefferson University

Stomach Neoplasms

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Stomach Cancer

Patients with upper gastro intestinal cancer who underwent surgery

Patients with upper gastro intestinal cancer who did not underwent surgery

Persons with no cancer who accepted to be control with blood samples and flow doppler ultrasound examination of both legs.

Ole Thorlacius-Ussing, Professor, DMSC, MD

Cancer is a well known risk factor for venous thromboembolism (VTE) such as deep venous thrombosis (DVT) and pulmonary embolism (PE). Today we know that patients with adenocarcinomas of the gastro intestinal tract (GI-tract) often is in a hypercoagulable state.

In our observational study we collect patients admitted to department with a tentative diagnosis of upper GI cancer including pancreas cancer and offer them flow doppler ultrasounds of both legs for diagnosis of DVT in the entire treatment time. The routine CT-scan of the chest is modified to diagnose PE. This will be compared with blood samples analysed for coagulation markers including D-dimer - a fibrinogen degradation product.

Armand Troussau observed back in 1865 a particular condition of the blood that predisposes to spontaneous coagulation in patients with gastric cancer. Today it is known that adenocarcinomas in the gastrointestinal (GI) tract including tumours of colon and rectum is accompanied by an hypercoagulable state.

Cancer is a well known risk factor for venous thromboembolism (VTE) such as deep venous thrombosis (DVT) and pulmonary embolism (PE). In fact PE in cancer patients is the second most common cause of death.

In an analysis of 13 cohort studies published with observational data Otten and Prins concludes that the prevalence of VTE in cancer patients varied between 10 and 20%. Variation could be explained with inconsistency. Patients suffering from thrombosis secondary to hemi paresis and paraplegia were included. Patients where included at time of VTE and not at time of cancer diagnosis.

Levitan et al looked at discharge diagnosis in 1211944 cancer patients and found among gastric cancer patients a frequency of VTE at 85 per 10000 patients and in pancreatic cancer 110 per 10000. Gastric cancer patients had a relative risk of 1.49 compared to non-cancer patients and pancreatic cancer patients a relative risk of 2.05 compared to non-cancer patients. This put pancreatic cancer among the most prone malignancy to cause thromboembolic complications. In a newly published study of 202 pancreatic cancer patients 19 developed venous thrombosis resulting in a 58 fold increased risk compared to general population with an incidence of 108/1000 patient-years and cumulative incidence after 6 months of 74/1000. 15 out of 19 cases of VTE occurred in the first 6 months since diagnosis of cancer. Tumours located in the corpus or cauda had twice the risk of caput. Chemotherapy resulted in a 4.8 fold risk of venous thrombosis.

Postoperatively VTE is higher in cancer patients than in non-cancer patients after surgery. A multicenter study including Danish patients - using phlebography - has shown VTE in 23% of patients after surgery for colorectal cancer. Coagulation activity - as assessed by sensitive biochemical markers - was related to tumour load.

Stender et al has in a newly published study shown a high preoperative prevalence of DVT in 193 colorectal cancer patients with a prevalence of 16% in women and 2.6% in men. In another newly published study asymptomatic DVT is found ovarian cancer patients with elevated levels of D-Dimer before treatment. The mechanism by which cancer induce VTE is at present subject to great interest.

Plasma D-dimer (DD), a degradation product of cross-linked fibrin, is routinely used to support or exclude the tentative diagnosis of DVT, combined with clinical assessment and ultrasonography (US).

The accuracy of DD assays in cancer patients is unknown, despite their high negative predictive values (NPV) in non cancer patients. A negative DD seems to exclude PE in cancer patients, but DD in combination imaging techniques such as US or computed tomography (CT) seems to improve diagnostic work-up but needs further investigation.

Blood samples with seperation in plasma and serum. Urin samples. tumour tissue samples.

Venous Thromboembolism and Haemostatic Disturbances in Patients With Upper Gastrointestinal Cancer

University of Aarhus

Nervous System Diseases

Hemorrhage

Glioma

Intracranial Hemorrhages

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Neuroepithelioma

Fibrinolytic Agents

Heparin

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

patients who have switched from low molecular weight heparin (LMWH) to apixaban at the recommended dose of the treating physician.

FDA approved dose 10 mg twice daily (BID) for 7 days followed by 5 mg PO BID OR physician prescribed dose

The treating physician will initiate and prescribe the apixaban, the protocol will only observe and record intracranial pressure (ICP) and VTE incidences.

Observation of ICH and VTE

Stuart A Grossman, MD

Glioma patients with history of venous thromboembolism (VTE) treated on low molecular weight heparin (LMWH) and who decided with their physician to convert to Apixaban (oral drug) will be enrolled into our study and will collect data regarding recurrent VTE and Intracranial hemorrhage and the incidence of these events.

Primary Objectives To estimate the incidence of intracranial hemorrhage (ICH) in glioma patients with history of venous thromboembolism (VTE) after the conversion from low molecular weight heparin (LMWH) injections to oral Apixaban.

Secondary Objective To estimate the incidence of recurrent VTE in glioma patients with history of venous thromboembolism after the conversion from low molecular weight heparin (LMWH) injections to oral Apixaban.

Incidence of Intracranial Hemorrhage in Glioma Patients With Venous Thromboembolism Converted From LMWH to Apixaban

Observe subject to determine the incidence of ICH during standard of care (SOC) observations.

Observe subject to determine the incidence of VTE during SOC observations.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lipid Regulating Agents

Bone Density Conservation Agents

Rosuvastatin Calcium

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Calcium

Calcium, Dietary

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

This arm will receive rosuvastatin during the first treatment period followed by placebo in the second treatment period after washout.

This arm will receive placebo during the first treatment period followed by rosuvastatin in the second treatment period after washout.

Rosuvastatin

Placebo

Steven Ades, MD, MSc

Patients with cancer have a high risk of developing venous blood clots or thromboembolism (VTE). In an effort to target patients at highest risk of VTE for thromboprophylaxis (protective treatment for blood clots), numerous studies have identified serum biomarkers for risk of future VTE. There is also increasing evidence pointing to a prophylactic effect of statin therapy on the risk of developing VTE in high-risk populations including patients with advanced cancer. The purpose of this research study is to find out whether treatment with rosuvastatin (the study drug) reduces the risk of VTE in patients with cancer receiving chemotherapy. This study is specifically investigating the impact of rosuvastatin therapy on serum biomarkers (D-dimer and others) that indicate a risk for VTE, as well as safety and tolerance of rosuvastatin therapy in this population.

This is a phase II randomized crossover study with two 3-4 week treatment periods during which all enrolled patients will receive 20 mg of rosuvastatin once a day by mouth or a matching placebo tablet. Approximately two tablespoons of blood will be collected for biomarker analysis at the beginning and end of each treatment period. After the first treatment period there will be a 3-5 week break where subjects will undergo a washout. Following this washout period every subject will "crossover" or begin taking the alternative therapy so everyone enrolled will receive the study drug either during the first or the second treatment period. Biomarker levels will be analyzed in both treatment periods and compared to baseline, with every patient acting as their own control.

Detecting the Impact of Statin Therapy On Lowering Risk of Venous Thrombo-Embolic Events (DISOLVE)

Impact of Rosuvastatin on Risk Markers of Venous Thromboembolism During Systemic Therapy for Advanced Cancer

University of Vermont

Assistant Professor of Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Correlation of a D-dimer Testing Protocol With Venous Thromboembolism in Surgical Colorectal Patients	NCT05246943	Venous Thrombos... Colorectal Canc... Diverticular Di... Crohn Disease Ulcerative Coli... Deep Vein Throm...	D-dimer and low...	18 Years -	The University of Texas Medical Branch, Galveston
Pharmacokinetics of Apixaban in Patients Undergoing Pancreaticoduodenectomy	NCT04191928	Pancreas Cancer DVT Pulmonary Embol...	Apixaban	18 Years - 65 Years	Thomas Jefferson University
Venous Thromboembolism and Haemostatic Disturbances in Patients With Upper Gastrointestinal Cancer	NCT00660205	Thrombosis Deep Venous Thr... Pulmonary Embol... Venous Thromboe... Pancreas Cancer Esophagus Cance... Gastric Cancer		15 Years - 85 Years	University of Aarhus
Venous Thromboembolism and Haemostatic Disturbances in Patients With Upper Gastrointestinal Cancer	NCT00660205	Thrombosis Deep Venous Thr... Pulmonary Embol... Venous Thromboe... Pancreas Cancer Esophagus Cance... Gastric Cancer		15 Years - 85 Years	University of Aarhus
The Correlation of a D-dimer Testing Protocol With Venous Thromboembolism in Surgical Colorectal Patients	NCT05246943	Venous Thrombos... Colorectal Canc... Diverticular Di... Crohn Disease Ulcerative Coli... Deep Vein Throm...	D-dimer and low...	18 Years -	The University of Texas Medical Branch, Galveston
Incidence of Intracranial Hemorrhage in Glioma Patients With Venous Thromboembolism Converted From LMWH to Apixaban	NCT04895553	Glioma, Maligna...	Observation of ...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Detecting the Impact of Statin Therapy On Lowering Risk of Venous Thrombo-Embolic Events (DISOLVE)	NCT01524653	Venous Thromboe... Deep Vein Throm... Neoplasms	Rosuvastatin Placebo	18 Years -	University of Vermont

Spots Global Cancer Trial Database for dvt

Every month we try and update this database with for dvt 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 dvt

Every month we try and update this database with for dvt 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 dvt 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.