Clinical trial NCT03993977: ROTEM-guided Transfusion Protocol in Attempt to Reduce Blood Transfusions in Major Oncological Surgery
Official title: ROTEM-guided Transfusion Protocol Versus Standard Care in Attempt to Reduce Blood Transfusions in Potentially Curative Major Abdominal and Urological Oncological Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Blood Loss, Surgical
Blood Loss Requiring Transfusion
Coagulation Defect; Acquired
Keywords: ROTEM
thromboelastometry
blood transfusion
cancer
surgery
abdominal
oncological
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Number of transfused red blood cell (RBC) units
timeFrame: 24 hours after beginning of surgery
Secondary outcomes:
measure: Intensive care admissions
timeFrame: 30 days after surgery
measure: Length of hospital stay
timeFrame: 30 days after surgery
measure: Transfusion-related side effects
timeFrame: 30 days after surgery
measure: Thromboembolic events
timeFrame: 30 days after surgery
Other outcomes:
measure: Signs of altered coagulation
timeFrame: 12-24 hours after surgery
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Deputy chief physician
name: Anne Kuitunen, MD, PhD
role: STUDY_DIRECTOR
References: