Symptoms and General Pathology

All Conditions

Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Rare Diseases

Hemorrhage

Glioma

Hemostatic Disorders

Blood Coagulation Disorders

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Hematologic Diseases

Vascular Diseases

Hemorrhagic Disorders

Acute Graft Versus Host Disease

Neuroepithelioma

Coagulants

All Drugs and Chemicals

Herbal and Botanical

Hemostatics

Cola

Patients undergoing elective glioma resection

Patients undergoing elective colon cancer resection

The following blood samples will be drawn for hemostasis evaluation: 1. Conventional clotting tests, 2. Rotational thromboelastometry (ROTEM), including EXTEM and FIBTEM; 3. Platelet function as assessed by PFA-200 for; and 4. Platelet function as assessed by ara-tem, adp-tem and trap-tem. All the analyses will be performed before (within a period 24-h before surgery) and after (within of the following periods: 2 h, 24 h and 48 h after surgery).

Exposure to glioma resection surgery

Exposure to colon resection surgery

Santiago R. Leal-Noval, MD Ph.D

Santiago R Leal-Noval, MD

Prospective, observational study aimed to investigate the specific hemostatic alterations in patients undergoing glial tumor resection.

Brain parenchyma express tissue factor and other coagulation factors in high concentrations. In addition, neuro critical patients (NCP) may present platelet dysfunction, hyperfibrinolysis, hypo coagulation and / or hyper coagulation status, early after the injury. It is not known whether these alterations of hemostasis are due to a specific brain response to aggression, or they are included into a systemic response. This prospective, observational study is aimed to investigate the coagulation disorders specifically associated with cerebral aggression.

This is a prospective, cohort study including (calculated sample size) a study group of patients undergoing elective surgery (glial tumors) and other one undergoing colo rectal surgery. Alterations of the hemostasis will be evaluated by clotting tests, thromboelastometry and tests for platelet function. Samples will be drawn before and after surgical procedures. Multiple statistical comparisons intra and inter groups will be performed.

Hemostasis Alterations in Neurosurgical Patients

Prospective Study on Hemostasis Alterations in Patients Undergoing Neuro Surgical Glioma Resection Acronym: (ABCD Study: Acute Brain Coagulopathy Development Study)

Blood samples for assessing INR (clotting tests) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.

Blood samples for assessing aPTT (clotting tests) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.

Blood samples for assessing CT / EXTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.

Blood samples for assessing MCF / EXTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.

Blood samples for assessing ML (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.

Blood samples for assessing col EPI (measured by platelet function analyzer : PFA-200 test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.

Blood samples for assessing A6 (amplitude at 6 minutes, ohm), MS (maximum slope, ohm/min), and AUC (area under curve, ohm\* min), all of then measured by platelet function analyzer ROTEM will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.

Blood samples for assessing CT / FIBTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.

Blood samples for assessing MCF / FIBTEM (measured by thromboelastometry test) will be drawn in these periods of time "t": "t0" (before surgery) and t1 (2-hour after surgery), t2 (24-hour after surgery) and t3 (48-hour after surgery). Changes from t0 to t1, t2 and / or t3 will be considered.

Any bleeding occurring during this period.

Instituto de Salud Carlos III

Santiago R. Leal-Noval

Santiago R. Leal-Noval, MD, PhD, Critical Care specialist

Leukemia

Leukemia, Promyelocytic, Acute

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Acute Promyelocytic Leukemia

patients with de novo acute promyelocytic leukemia with hemorrhage.

Jin Zhou, MD, PhD

Although the clinical application of differentiation therapy has made great success in the treatment of acute promyelocytic leukemia (APL), early fatal bleeding remains an unsolved problem which accounts for the main reason of induction failure in APL patients. The clinical manifestation of both serious bleeding and thrombosis illustrate the complexity of the pathogenesis of coagulopathy in APL. Despite extensive research, the pathogenesis of coagulopathy in APL is still unclear. Microparticles, 0.11μm in diameter, are small membrane vesicles released to circulation by blood cells and vascular endothelial cells during activation or apoptosis. Microparticles (MPs) derived from different cells types all exert procoagulant activity mediated by phosphatidylserine (PS) and carry some basic substances derived from their origin cells. Also, the biological activity of microparticles is often significantly higher than that of the cells they come from. According to these problems and background knowledge, our project aims to observe the roles of microparticles derived from APL cells and the procoagulant or profibrinolytic activating factors resided on these microparticles in the pathogenesis of coagulopathy in APL, and the effects of different induction therapies, chemotherapeutic drugs or differentiation agents on these microparticles and their procoagulant or profibrinolytic activating factors. To carry out this study, microparticles are obtained from patients who undergo different induction therapies at different time points or from primary bone marrow APL cells which are treated by different drugs in vitro at different time points, the expressions and activities of five procoagulant or profibrinolytic activating factors, which are highly expressed in APL cells, PS exposure and the functional state of these microparticles, will be dynamically monitored. Further study of the pathogenesis of coagulopathy in APL can provide clues and help for deep understanding of clinical manifestations, guiding clinical treatment as well as judging prognosis, and establishing theoretical basis for exploring new treatment.

The investigators plan to measure routine laboratory parameters of coagulation and fibrinolysis, the procoagulant or profibrinolytic activity of microparticles (MPs), and explore the role of the procoagulant and profibrinolytic activating factor of MPs in the pathogenesis of coagulopathy in patients with APL.

i. Dynamic turbidimetry of plasma clot formation. The effects of MPs on the kinetics of fibrin formation and on the optical properties of clots are studied using dynamic turbidimetry of re-calcified plasma samples (platelet-free plasma and microparticle-depleted plasma) without adding any clotting activator. Clotting of plasma samples induced by Ca2+ is followed by monitoring the optical density at λ = 405 nm at 37 °C.

ii. Thrombin generation assay. The amount of thrombin formed in plasma upon re-calcification is measured directly using a modified thrombin generation test . Because fibrin interferes with colorimetric measurements, plasma samples are first defibrinated by adding reptilase followed by incubation at 37 °C. The clots are removed. Then a chromogenic substrate for thrombin is added to the plasma samples. Thrombin generation is started by adding CaCl2 with simultaneous recording of the absorbance at λ = 405 nm.

iii. Thrombin generating capacity of the MPs. MPs are reconstituted in defibrinated (reptilase treated), normal pooled microparticle-depleted plasma. Then a chromogenic substrate for thrombin is added to the samples. Thrombin generation is started by adding CaCl2 with simultaneous recording of the absorbance at λ = 405 nm.

iv. Thrombin generation inhibitory experiments. The following inhibitors are pre-incubated with the microparticles: Annexin V, anti-human tissue factor (TF) and irrelevant control immunoglobulin G (IgG). Then repeats the experiment iii.

v. Fibrinolytic activity. Incubate a fixed concentration of plasminogen with the plasma samples in the presence of a chromogenic substrate selective for plasmin. Plasmin formed from plasminogen bound at the surface of microparticles cleaves the chromogenic substrate and the released p-nitroaniline is detected by measuring A405nm as a function of time.

vi. Determination of fibrinolytic activity on microparticles. The capacity of microparticles to activate plasminogen is determined by incubating a fixed concentration of plasminogen (1mM) with the microparticles with or without t-PA and/or u-PA in the presence of a chromogenic substrate selective for plasmin. Plasmin formed from plasminogen bound at the surface of microparticles cleaves the chromogenic substrate and the released p-nitroaniline is detected by measuring A405nm.

vii. Fibrinolytic activity inhibitory experiments. The following inhibitors are pre-incubated with the microparticles: anti-human tissue type plasminogen activator (tPA) , anti-human urokinase type plasminogen activator (uPA), and respective irrelevant control IgGs; ε-aminocaproic acid and plasminogen activator inhibitor-1 (PAI-1).Then repeat the experiment vi.

Venous blood from patients with acute promyelocytic leukemia and from healthy volunteers is collected into 0.119M sodium citrate Vacuum tubes. platelet-free plasma is prepared within 4h using 2 serial centrifugations ( 15min at 1,500g, 2 min at 13,000g) and stored at -80℃ until use. A portion of PFP was filtered through a 0.1-um-pore size filter to collect microparticle-depleted plasma and stored at -80℃ until use. Experiments concerning procoagulant activity are detected immediately after blood collection.

Role of Microparticles in the Coagulopathy of Acute Promyelocytic Leukemia

Demonstration that the some procoagulant or profibrinolytic activating factors expressed on MP in APL patients' plasma associate with the thrombin generating capacity and fibrinolytic activity of patients' plasma.

First Affiliated Hospital of Harbin Medical University

Respiratory Tract (Lung and Bronchial) Diseases

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Malignant Mesothelioma

TEG analysis of blood from patients at different points in time

Blood draw for TEG analysis

Ju-Mei Ng, MD

Ju-Mei Ng

Surgery for malignant pleural mesothelioma is complex and prolonged, and may involve significant blood loss with considerable blood and product transfusion. Thromboelastography (TEG) is a global assay of coagulation that uses whole blood to produce a tracing that records kinetic changes in clot formation. This study aims provide a better understanding of the coagulation profile of these patients, and will form the basis of a TEG-based transfusion algorithm for future surgeries for mesothelioma.

Thromboelastography can provide more in-depth and quicker analysis of the complex coagulation processes during surgery

Thromboelastography During Surgery for Malignant Pleural Mesothelioma

Reaction time, alpha angle, maximum amplitude and clot lysis from thromboelastography give a better picture of coagulation at different phases of surgery

Brigham and Women's Hospital

Instructor of Anaesthesia

Nervous System Diseases

Stroke

Ischemic Stroke

Ischemia

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Fibrinolytic Agents

Anticoagulants

Anti-Arrhythmia Agents

Channel Blockers

Vasodilator Agents

Anti-Infective Agents

Amino Acids

Enoxaparin

Edoxaban

Verapamil

Fibrin fragment D

Enoxaparin sodium

Quinidine

Quinidine gluconate

Factor Xa Inhibitors

Antithrombins

Antithrombin III

Protease Inhibitors

Serine Proteinase Inhibitors

HIV Protease Inhibitors

Enzyme Inhibitors

Serine

Edoxaban, per oral, 60mg qd (may consider reduced dose to 30mg qd in patients with proper clinical reason by attending physician, estimated creatinine clearance of 30 to 50 ml per minute, a body weight of 60 kg or less, or the concomitant use of verapamil or quinidine), for 90 days.

Enoxaparin, subcutaneous injection, 1mg/kg BID (may consider reduced dose to 1mg/kg qd in patients with proper clinical reason by attending physician, Creatinine clearance \<30 mL/min), for 90 days.

Oh Young Bang, MD PhD

Jong-Won Chung, MD MSc

Purpose: Cancer-related hypercoagulability plays an important role in the development of cancer-related stroke. With rapidly aging population and increasing cancer prevalence, cancer related stroke has become an important stroke subtype. Recent studies suggest that hypercoagulability is associated with poor prognosis and effective correction of coagulopathy maybe protective for survival in cancer related stroke patients. Optimal strategies to correct coagulopathy in cancer stroke patient remains to be determined. Currently, the use of low molecular-weighted heparin is recommended in these patients, but non-vitamin K oral anticoagulants (NOACs) could be safe alternative without the need for injection subcutaneously. Furthermore, NOACs could be an optimal treatment strategy for cancer-related stroke in terms of correcting coagulopathy with less injection related complication (ex. pain and infection) compared to Enoxaparin.

Edoxaban for the Treatment of Coagulopathy in Patients With Active Cancer and Acute Ischemic Stroke: a Pilot Study. (ENCHASE Study)

interval change of serum D-dimer level between day 0 and 7

number of micro-embolic signal detected by transcranial doppler

modified Rankin scale at 90 days, from 0 to 6, higher is worse

symptomatic intracerebral hemorrhage major bleeding all-cause death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hemostasis Alterations in Neurosurgical Patients	NCT02652897	Glioma Coagulopathy Acquired Platel... Thromboelastome... Surgery	Exposure to gli... Exposure to col...	18 Years -	Hospitales Universitarios Virgen del Rocío
Role of Microparticles in the Coagulopathy of Acute Promyelocytic Leukemia	NCT02991066	Acute Promyeloc...		18 Years -	First Affiliated Hospital of Harbin Medical University
Thromboelastography During Surgery for Malignant Pleural Mesothelioma	NCT01912547	Coagulopathy Mesothelioma	Blood draw for ...	18 Years -	Brigham and Women's Hospital
Edoxaban for the Treatment of Coagulopathy in Patients With Active Cancer and Acute Ischemic Stroke: a Pilot Study. (ENCHASE Study)	NCT03570281	Correction of C...	Edoxaban Enoxaparin	20 Years -	Samsung Medical Center
Hemostasis Alterations in Neurosurgical Patients	NCT02652897	Glioma Coagulopathy Acquired Platel... Thromboelastome... Surgery	Exposure to gli... Exposure to col...	18 Years -	Hospitales Universitarios Virgen del Rocío
Edoxaban for the Treatment of Coagulopathy in Patients With Active Cancer and Acute Ischemic Stroke: a Pilot Study. (ENCHASE Study)	NCT03570281	Correction of C...	Edoxaban Enoxaparin	20 Years -	Samsung Medical Center

Spots Global Cancer Trial Database for coagulopathy

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