Symptoms and General Pathology

All Conditions

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Heart and Blood Diseases

Blood and Lymph Conditions

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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

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Vascular Diseases

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Acute Graft Versus Host Disease

Neuroepithelioma

Coagulants

All Drugs and Chemicals

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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

Digestive System Diseases

Colorectal Neoplasms

Postoperative Complications

Neoplasm Metastasis

Intestinal Neoplasms

Thromboembolism

Venous Thromboembolism

Carcinoma

Peritoneal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Thrombosis

Embolism

Embolism and Thrombosis

Abdominal Neoplasms

Peritoneal Diseases

48 patients with peritoneal metastases from colorectal cancer undergoing cytoreductive surgery with HIPEC (cytoreductive surgery with HIPEC patients)

48 rectal cancer patients undergoing minimally invasive rectal cancer resection

Anne-Mette Hvas, MD, PhD

Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) has prolonged the survival substantially for selected patients with peritoneal metastases from colorectal cancer.Bleeding and thromboembolic disease have been reported as postoperative complications related to this advanced open surgical treatment. However, perioperative changes in coagulation and fibrinolysis are only sparsely reported in the literature.The mainstay of treatment with curative intend of none-advanced colorectal cancer is minimally invasive laparoscopic surgery followed by adjuvant chemotherapy. The approach is considered associated with a lower risk of thromboembolic disease than open surgery. Despite differences in extent of surgery and thromboembolic risk the same extended thromboprophylaxis regimen for 28 days is currently prescribed to patients undergoing cytoreductive surgery with HIPEC as well as minimally invasive rectal cancer resection. This study aims to investigate all parts of the coagulation system and fibrinolysis, and thereby thromboembolic risk and potential bleeding in two groups of patients with different extent of surgical trauma: 1) Colorectal cancer patients undergoing cytoreductive surgery with HIPEC and 2) rectal cancer patients undergoing minimal invasive rectal cancer resection. Our hypothesis is that patients undergoing cytoreductive surgery with HIPEC are exposed to more aggravated alterations of coagulation and fibrinolysis than patients undergoing minimally invasive rectal cancer resection.

Changes in Coagulation in Colorectal Cancer Patients Undergoing Surgical Treatment

The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.

The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.

Thrombin generation will be measured by:

Lagtime (min), time to peak (min), peak thrombin (nM) and endogenous thrombin potential (nM\*min).

The difference between changes of fibrin clot structure from before surgery to the end of surgery in cytoreductive surgery with HIPEC patients and patients undergoing minimally invasive rectal cancer resection.

Fibrin clot structure will be measured by clot maximum, absorbance (arbitrary units), network density, lysis time (seconds), lysis area (balance between clot formation and lysis).

The difference will be measured in blood samples from before surgery to the end of surgery (both groups).

ROTEM will include EXTEM, INTEM, FIBTEM, and APTEM by clotting time (seconds), clot formation time (seconds), alpha-angle (degrees), amplitude 10 min after clotting time (mm), maximum clot firmness (mm), lysis index 30 min after clotting time (mm), maximum lysis (mm).

The difference will be measured in blood samples from before surgery to the end of surgery in cytoreductive surgery.

The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end HIPEC.

The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC.

The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC. Thrombin generation will be measured by: Lagtime (min), time to peak (min), peak thrombin (nM) and endogenous thrombin potential (nM\*min).

The difference will be measured in blood samples from the end of cytoreductive surgery (before HIPEC) to the end of HIPEC. Fibrin clot structure will be measured by clot maximum, absorbance (arbitrary units), network density, lysis time (seconds), lysis area (balance between clot formation and lysis).

The difference will be measured in blood samples from the end of cytoreductive surgery to the end HIPEC.

ROTEM will include EXTEM, INTEM, FIBTEM, and APTEM by clotting time (seconds), clot formation time (seconds), alpha-angle (degrees), amplitude 10 min after clotting time (mm), maximum clot firmness (mm), lysis index 30 min after clotting time (mm), maximum lysis (mm).

Bilateral doppler ultrasonography of the veins in the lower extremities.The scan will be performed within the postoperative period from day 3 to day 7.

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
Changes in Coagulation in Colorectal Cancer Patients Undergoing Surgical Treatment	NCT04744688	Peritoneal Meta... Peritoneal Carc... Colorectal Neop... Intestinal Neop... Cytoreductive S... Venous Thromboe... Bleeding Laparoscopic Su... Coagulation Surgical Proced... Postoperative C... Laparoscopy Minimally Invas... Surgical Oncolo...		18 Years -	University of Aarhus
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 coagulation

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

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