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

Not Applicable

Withdrawn

• Conditions: Blood Loss, Surgical; Blood Loss Requiring Transfusion; Coagulation Defect; Acquired
• Interventions: Diagnostic Test: Rotational thromboelastometry; Other: Conventional treatment

• Registration Number: NCT03993977
• Lead Sponsor: Tampere University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-06-20
• Study First Posted: 2019-06-21
• Study Start: 2020-05-01
• Primary Completion: 2020-10-13
• Study Completion: 2020-10-13
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ROTEM-arm	Rotational thromboelastometry	Treatment of significant blood loss using point-of-care testing of whole blood viscoelasticity (ROTEM) monitoring coagulopathy or hyperfibrinolysis.
Control-arm	Conventional treatment	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland