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

NCT03993977 | Withdrawn

• 1 other identifier: ETL R17025
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Intensive care admissions

  30 days after surgery

• Length of hospital stay

  30 days after surgery

• Transfusion-related side effects

  30 days after surgery

• Thromboembolic events

  30 days after surgery

Other Outcomes (1)

• Signs of altered coagulation

  12-24 hours after surgery

Study Arms (2)

ROTEM-arm

EXPERIMENTAL

Treatment of significant blood loss using point-of-care testing of whole blood viscoelasticity (ROTEM) monitoring coagulopathy or hyperfibrinolysis.

Diagnostic Test: Rotational thromboelastometry

Control-arm

ACTIVE COMPARATOR

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

Interventions

Rotational thromboelastometry DIAGNOSTIC_TEST

ROTEM-guided protocol of hemostatic resuscitation

Also known as: ROTEM

ROTEM-arm

Conventional treatment OTHER

Clinical judgement and conventional coagulation tests

Control-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known hemophilia or von Willebrandt's disease (treatment planned beforehand in collaboration with haematologist), unacceptance of allogeneic blood products (jehovah's witnesses).

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Hospital

Tampere, 33560, Finland

Location

MeSH Terms

Conditions

Blood Loss, Surgical; Hemostatic Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Anne Kuitunen, MD, PhD

  Deputy chief physician

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 21, 2019
• Study Start: May 1, 2020
• Primary Completion: October 13, 2020
• Study Completion: October 13, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

FI (1)