Heart and Blood Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Blood and Lymph Conditions

Rare Diseases

Thrombosis

Neoplasm Metastasis

Polycythemia

Polycythemia Vera

Hematologic Diseases

Bone Marrow Neoplasms

Hematologic Neoplasms

Bone Marrow Diseases

Myeloproliferative Disorders

Chronic Myeloproliferative Disorders

Patients with polycythemia defined as hematocrit level greater than or equal to 49% in men and 48% in women, whatever the suspected etiology. Primitive and secondary polycythemia are eligible in this observational study. Patients should not have start any cytoreductive therapy prior inclusion.

Mael HEIBLIG, MD,PhD

Polycythemia (PG) corresponds to an increase in erythrocyte parameters on a blood test. A distinction is usually made between primary and secondary PG. The most common primary PG is Vaquez's disease, a hematological cancer. In Vaquez disease, an increase in hematocrit has been reported to be associated with a logarithmic increase in blood viscosity.

The main complications of primary PGs (especially in Vaquez disease) are thromboembolic complications. In contrast, thromboembolic complications are rarer in secondary PG. In Vaquez disease, a hematocrit ≤ 45% has been defined as the therapeutic goal for significantly reducing thromboembolic risk. However, this has not been established for secondary PGs. All in all, the definition of the 45% threshold is based solely on clinical studies with no obvious biological argument. What's more, simply lowering blood mass through cytoreduction alone does not appear to be sufficient to significantly reduce thromboembolic risk.

To investigator knowledge, there are no studies prospectively evaluating blood viscosity, its determinants and coagulation in different types of polycythemia. Nor are there any data on the direct effect on blood viscosity of the various treatments usually offered.

Blood Viscosity in Polycythemia Patients

Evaluation of Blood Viscosity and Hyperviscosity-related Complications Relationship in Patients With Patients With Polycythemia

The investigators expect higher blood viscosity values in polyglobulic patients with symptoms of clinical hyperviscosity than in polyglobulic patients without symptoms of clinical hyperviscosity, but no differences in hematocrit between the two polycythemia groups

Hospices Civils de Lyon

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

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

Blood Loss, Surgical

Intraoperative Complications

Thrombin

Treatment of significant blood loss using point-of-care testing of whole blood viscoelasticity (ROTEM) monitoring coagulopathy or hyperfibrinolysis.

Treatment of significant blood loss conventionally, ie. using massive transfusion protocol if necessary, clinical judgement and conventional coagulation tests, such as prothrombin time (as international normalized ratio, INR), activated partial thrombin time (APTT), fibrinogen in plasma (Clauss method).

ROTEM-guided protocol of hemostatic resuscitation

Rotational thromboelastometry

Clinical judgement and conventional coagulation tests

Conventional treatment

Anne Kuitunen, MD, PhD

Need for perioperative blood transfusion is still high in certain types of oncological abdominal surgery. Allogeneic blood transfusion may be detrimental in cancer patients undergoing a potentially curative resection of malignant tumor, although the detailed mechanism of this effect is still under debate. We plan to evaluate whether a new, rotational thromboelastography-guided algorithm (ROTEM) to guide hemostatic resuscitation intra-operatively decreases the use of allogeneic blood products, the total amount of bleeding, transfusion related side effects, thromboembolic complications and costs. Its effect on each patient's post-operative hemostatic profile is also measured. 60 patients having a potentially curative pancreaticoduodenectomy (or resection of cauda of pancreas), total removal or partial resection of kidney and open radical cystectomy are recruited when an active blood loss of more than 1500 ml is estimated and/or measured and are randomized into two groups: one will be treated conventionally, ie. using massive transfusion protocol (MTP) if necessary, clinical judgement and conventional coagulation tests, the other treated using a ROTEM-based algorithm.

60 patients having a potentially curative abdomino-oncological surgery and reaching an active blood loss of more than 1500 ml are randomized into two groups. One will be treated conventionally, ie. using MTP if necessary, clinical judgement and conventional coagulation tests, the other treated using a ROTEM-based algorithm. Randomization (ratio 1:1 in blocks of 10) between the two groups will be done beforehand. Each paper containing the treatment protocol in question will be put into a closed envelope. The envelopes are numbered from 1 to 60 and are placed in a box in the operative department.

Participants do not know which group he/she is randomized into. They are under general anaesthesia, thus not knowing which protocol is used. When assessing outcomes, two groups are labeled only by number: the assessor does not know which arm is number 1 or 2 until whole data is analyzed.

ROTEM-guided Transfusion Protocol in Attempt to Reduce Blood Transfusions in Major Oncological Surgery

ROTEM-guided Transfusion Protocol Versus Standard Care in Attempt to Reduce Blood Transfusions in Potentially Curative Major Abdominal and Urological Oncological Surgery

Possible signs hypercoagulopathy in thromboelastometry: EXTEM value of more than 72 mm

Red blood cell units transfused per patient during operation or up to 24 hours after beginning of surgery

Number of patients admitted to intensive care or high dependency, if this is considered associating with the surgery

Number of days patient is in hospital immediately after surgery

Any side-effect considered or suspected originating from blood product transfusion

Clinically diagnosed deep vein thrombosis, pulmonary embolism, stroke or other thromboembolic event

Tampere University Hospital

Musculoskeletal Diseases

Bone Neoplasms

Bone Diseases

Pre- and postoperative blood sampling for ROTEM assessment in THR patients

Pre- and postoperative blood sampling for ROTEM assessment before and after THR in patients with bone neoplasm

Marek Janiak, MD

Jan Pluta, MD

Total hip replacement (THR) is associated with extensive tissue injury and considerable blood loss that can be complicated by hyperfibrinolysis with an increased need for blood transfusion. THR in patients with cancer involving the hip joint, can reduce pain and improve or maintain the function and quality of life. However, these patients have an increased likelihood of haemostatic abnormalities, such as thrombosis or extensive blood loss. Rotational thromboelastometry is a point-of-care viscoelastic assay that can provide a measure of coagulation disorders in the above settings, and this is still under review. The objective of this prospective cohort study is to quantitate the changes in clot formation dynamics following THR with a subgroup analysis of patients with cancer.

Impact of Surgical Injury on Haemostatic Tests in Patients Undergoing Total Hip Replacement With Subgroup Analysis of Patients With Neoplasm

Impact of Surgical Injury on Global Haemostatic Tests in Patients Undergoing Total Hip Replacement With Subgroup Analysis of Patients With Bone Neoplasm. A Single-centre Observational Prospective Trial

Pulmonary embolism, deep and superficial vein thrombosis

Instrument for measuring outcome following surgery with higher scores representing better function. Score from 0 to 100.

Health related Quality of Life measure. Higher score indicates better health state with eight scaled scores each from 0 to 100.

The ends of the scale are defined as the extreme limits of the pain. Orientated from the left (no pain) to the right (worst imaginable pain) measured in millimeters from 0 to 100.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Blood Viscosity in Polycythemia Patients	NCT06421025	Polycythemia Se... Polycythemia, P...		18 Years -	Hospices Civils de Lyon
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
ROTEM-guided Transfusion Protocol in Attempt to Reduce Blood Transfusions in Major Oncological Surgery	NCT03993977	Blood Loss, Sur... Blood Loss Requ... Coagulation Def...	Rotational thro... Conventional tr...	18 Years -	Tampere University Hospital
Blood Viscosity in Polycythemia Patients	NCT06421025	Polycythemia Se... Polycythemia, P...		18 Years -	Hospices Civils de Lyon
Impact of Surgical Injury on Haemostatic Tests in Patients Undergoing Total Hip Replacement With Subgroup Analysis of Patients With Neoplasm	NCT04442373	Total Hip Repla... Thromboelastome... Bone Neoplasm o...	Rotational thro...	18 Years -	Medical University of Warsaw
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

Spots Global Cancer Trial Database for thromboelastometry