Blood Loss Requiring Transfusion, Blood Loss, Surgical, Coagulation Defect; Acquired
Conditions
Keywords
ROTEM, thromboelastometry, blood transfusion, cancer, surgery, abdominal, oncological
Brief summary
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.
Interventions
DIAGNOSTIC_TESTRotational thromboelastometry
ROTEM-guided protocol of hemostatic resuscitation
OTHERConventional treatment
Clinical judgement and conventional coagulation tests
Sponsors
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of transfused red blood cell (RBC) units | 24 hours after beginning of surgery | Red blood cell units transfused per patient during operation or up to 24 hours after beginning of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensive care admissions | 30 days after surgery | Number of patients admitted to intensive care or high dependency, if this is considered associating with the surgery |
| Length of hospital stay | 30 days after surgery | Number of days patient is in hospital immediately after surgery |
| Transfusion-related side effects | 30 days after surgery | Any side-effect considered or suspected originating from blood product transfusion |
| Thromboembolic events | 30 days after surgery | Clinically diagnosed deep vein thrombosis, pulmonary embolism, stroke or other thromboembolic event |
Other
| Measure | Time frame | Description |
|---|---|---|
| Signs of altered coagulation | 12-24 hours after surgery | Possible signs hypercoagulopathy in thromboelastometry: EXTEM value of more than 72 mm |
Countries
Finland
Outcome results
None listed