Symptoms and General Pathology

All Conditions

Heart and Blood Diseases

Blood and Lymph Conditions

Hemorrhage

Hemostatic Disorders

Blood Coagulation Disorders

Blood Loss, Surgical

Intraoperative Complications

Hematologic Diseases

Vascular Diseases

Hemorrhagic Disorders

Coagulants

All Drugs and Chemicals

Hemostatics

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

Neoplasms

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	Link
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
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

Spots Global Cancer Trial Database for rotational thromboelastometry