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

• ClinicalTrials.gov Identifier: NCT03993977
• Recruitment Status: Withdrawn
• First Posted: June 21, 2019
• Last Update Posted: December 16, 2020
• Sponsor: Tampere University Hospital
• Information provided by (Responsible Party): Tampere University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Blood Loss, Surgical; Blood Loss Requiring Transfusion; Coagulation Defect; Acquired	Diagnostic Test: Rotational thromboelastometry; Other: Conventional treatment	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: Double (Participant, 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.
• Primary Purpose: Treatment
• Official Title: ROTEM-guided Transfusion Protocol Versus Standard Care in Attempt to Reduce Blood Transfusions in Potentially Curative Major Abdominal and Urological Oncological Surgery
• Estimated Study Start Date: May 1, 2020
• Actual Primary Completion Date: October 13, 2020
• Actual Study Completion Date: October 13, 2020

Arms and Interventions

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 Name: 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

Outcome Measures

Primary Outcome Measures :

1. Number of transfused red blood cell (RBC) units [ Time Frame: 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 Outcome Measures :

1. Intensive care admissions [ Time Frame: 30 days after surgery ]
   Number of patients admitted to intensive care or high dependency, if this is considered associating with the surgery
2. Length of hospital stay [ Time Frame: 30 days after surgery ]
   Number of days patient is in hospital immediately after surgery
3. Transfusion-related side effects [ Time Frame: 30 days after surgery ]
   Any side-effect considered or suspected originating from blood product transfusion
4. Thromboembolic events [ Time Frame: 30 days after surgery ]
   Clinically diagnosed deep vein thrombosis, pulmonary embolism, stroke or other thromboembolic event

Other Outcome Measures:

1. Signs of altered coagulation [ Time Frame: 12-24 hours after surgery ]
   Possible signs hypercoagulopathy in thromboelastometry: EXTEM value of more than 72 mm

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

Finland

Tampere University Hospital

Tampere, Finland, 33560

Sponsors and Collaborators

Tampere University Hospital

Investigators

• Study Director: Anne Kuitunen, MD, PhD; Deputy chief physician

More Information

• Responsible Party: Tampere University Hospital
• ClinicalTrials.gov Identifier: NCT03993977
• Other Study ID Numbers: ETL R17025
• First Posted: June 21, 2019
• Last Update Posted: December 16, 2020
• Last Verified: December 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tampere University Hospital:

ROTEM; thromboelastometry; blood transfusion; cancer; surgery; abdominal; oncological

Additional relevant MeSH terms:

Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage; Blood Loss, Surgical; Pathologic Processes; Intraoperative Complications; Hematologic Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders