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

NCT03993977 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-12-16

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Rotational thromboelastometry

ROTEM-guided protocol of hemostatic resuscitation

OTHER

Conventional treatment

Clinical judgement and conventional coagulation tests

Sponsors & Collaborators

  • Tampere University Hospital

    lead OTHER

Principal Investigators

  • Anne Kuitunen, MD, PhD · Deputy chief physician

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2020-10-13
Completion
2020-10-13

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03993977 on ClinicalTrials.gov