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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Blood Loss, Surgical; Coagulation Defect; Acquired; Blood Loss Requiring Transfusion
• Intervention / Treatment: Diagnostic test: Rotational thromboelastometry; Other: Conventional treatment

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33560
    • Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ROTEM-arm; Treatment of significant blood loss using point-of-care testing of whole blood viscoelasticity (ROTEM) monitoring coagulopathy or hyperfibrinolysis.	Diagnostic test: Rotational thromboelastometry; ROTEM-guided protocol of hemostatic resuscitation; Other Names: ROTEM
ACTIVE_COMPARATOR: Control-arm; 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; Clinical judgement and conventional coagulation tests

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Investigators: Study Director: Anne Kuitunen, MD, PhD, Deputy chief physician

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2020
• Primary Completion (ACTUAL): October 13, 2020
• Study Completion (ACTUAL): October 13, 2020

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (ACTUAL): June 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: cancer; surgery; thromboelastometry; blood transfusion; ROTEM; abdominal; oncological
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Intraoperative Complications; Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage; Blood Loss, Surgical
• Other Study ID Numbers: ETL R17025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No