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

Blood Loss, Surgical Clinical Trial

— ROTEM-SUR  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03993977
• Other study ID #: ETL R17025
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: October 13, 2020

Study information

• Verified date: December 2020
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 13, 2020
• Est. primary completion date: October 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Blood Loss Requiring Transfusion
• Blood Loss, Surgical
• Coagulation Defect; Acquired
• Hemorrhage
• Hemostatic Disorders

Intervention

Diagnostic Test:
• Rotational thromboelastometry
ROTEM-guided protocol of hemostatic resuscitation

Other:
• Conventional treatment
Clinical judgement and conventional coagulation tests

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Signs of altered coagulation	Possible signs hypercoagulopathy in thromboelastometry: EXTEM value of more than 72 mm	12-24 hours after surgery
Primary	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	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
Secondary	Length of hospital stay	Number of days patient is in hospital immediately after surgery	30 days after surgery
Secondary	Transfusion-related side effects	Any side-effect considered or suspected originating from blood product transfusion	30 days after surgery
Secondary	Thromboembolic events	Clinically diagnosed deep vein thrombosis, pulmonary embolism, stroke or other thromboembolic event	30 days after surgery