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Due to changes in the surgical technique, no potential subjects anymore
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROTEM-arm | Experimental | Treatment of significant blood loss using point-of-care testing of whole blood viscoelasticity (ROTEM) monitoring coagulopathy or hyperfibrinolysis. |
|
| Control-arm | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotational thromboelastometry | Diagnostic Test | ROTEM-guided protocol of hemostatic resuscitation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of transfused red blood cell (RBC) units | Red blood cell units transfused per patient during operation or up to 24 hours after beginning of surgery | 24 hours after beginning of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive care admissions | Number of patients admitted to intensive care or high dependency, if this is considered associating with the surgery | 30 days after surgery |
| Length of hospital stay | Number of days patient is in hospital immediately after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Signs of altered coagulation | Possible signs hypercoagulopathy in thromboelastometry: EXTEM value of more than 72 mm | 12-24 hours after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Kuitunen, MD, PhD | Deputy chief physician | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere University Hospital | Tampere | 33560 | Finland |
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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.
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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.
| Conventional treatment | Other | Clinical judgement and conventional coagulation tests |
|
| 30 days after surgery |
| Transfusion-related side effects | Any side-effect considered or suspected originating from blood product transfusion | 30 days after surgery |
| Thromboembolic events | Clinically diagnosed deep vein thrombosis, pulmonary embolism, stroke or other thromboembolic event | 30 days after surgery |
| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| D020141 | Hemostatic Disorders |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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