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

Study Overview
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Brief Summary
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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.

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

Conditions
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Blood Loss, Surgical, Blood Loss Requiring Transfusion, Coagulation Defect; Acquired

Intervention / Treatment
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* Diagnostic Test: Rotational thromboelastometry
* Other: Conventional treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18, radical cystectomy, total or partial nephrectomy for malignant disease or pancreaticoduodenectomy planned and estimated intraoperative hemorrhage over 1500ml, written and informed consent Exclusion Criteria: Known hemophilia or von Willebrandt's disease (treatment planned beforehand in collaboration with haematologist), unacceptance of allogeneic blood products (jehovah's witnesses).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ROTEM-arm<br>Treatment of significant blood loss using point-of-care testing of whole blood viscoelasticity (ROTEM) monitoring coagulopathy or hyperfibrinolysis. | Diagnostic Test: Rotational thromboelastometry<br>* ROTEM-guided protocol of hemostatic resuscitation<br>* Other names: ROTEM;|
| Active Comparator: Control-arm<br>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). | Other: Conventional treatment<br>* Clinical judgement and conventional coagulation tests<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ROTEM, thromboelastometry, blood transfusion, cancer, surgery, abdominal, oncological