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

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ClinicalTrials.gov Identifier: NCT03993977
Recruitment Status : Withdrawn (Due to changes in the surgical technique, no potential subjects anymore)
First Posted : June 21, 2019
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital

Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date December 16, 2020
Estimated Study Start Date  ICMJE May 1, 2020
Actual Primary Completion Date October 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
Number of transfused red blood cell (RBC) units [ Time Frame: 24 hours after beginning of surgery ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
  • 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
  • Length of hospital stay [ Time Frame: 30 days after surgery ]
    Number of days patient is in hospital immediately after surgery
  • Transfusion-related side effects [ Time Frame: 30 days after surgery ]
    Any side-effect considered or suspected originating from blood product transfusion
  • Thromboembolic events [ Time Frame: 30 days after surgery ]
    Clinically diagnosed deep vein thrombosis, pulmonary embolism, stroke or other thromboembolic event
Original Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Intensive care admissions [ Time Frame: 30 days after surgery ]
  • Length of hospital stay [ Time Frame: 30 days after surgery ]
  • Transfusion-related side effects [ Time Frame: 30 days after surgery ]
  • Thromboembolic events [ Time Frame: 30 days after surgery ]
Current Other Pre-specified Outcome Measures
 (submitted: June 20, 2019)
Signs of altered coagulation [ Time Frame: 12-24 hours after surgery ]
Possible signs hypercoagulopathy in thromboelastometry: EXTEM value of more than 72 mm
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE ROTEM-guided Transfusion Protocol in Attempt to Reduce Blood Transfusions in Major Oncological Surgery
Official Title  ICMJE ROTEM-guided Transfusion Protocol Versus Standard Care in Attempt to Reduce Blood Transfusions in Potentially Curative Major Abdominal and Urological Oncological Surgery
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Blood Loss, Surgical
  • Blood Loss Requiring Transfusion
  • Coagulation Defect; Acquired
Intervention  ICMJE
  • Diagnostic Test: Rotational thromboelastometry
    ROTEM-guided protocol of hemostatic resuscitation
    Other Name: ROTEM
  • Other: Conventional treatment
    Clinical judgement and conventional coagulation tests
Study Arms  ICMJE
  • Experimental: ROTEM-arm
    Treatment of significant blood loss using point-of-care testing of whole blood viscoelasticity (ROTEM) monitoring coagulopathy or hyperfibrinolysis.
    Intervention: Diagnostic Test: Rotational thromboelastometry
  • 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).
    Intervention: Other: Conventional treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 14, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2019)
60
Actual Study Completion Date  ICMJE October 13, 2020
Actual Primary Completion Date October 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03993977
Other Study ID Numbers  ICMJE ETL R17025
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tampere University Hospital
Study Sponsor  ICMJE Tampere University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Anne Kuitunen, MD, PhD Deputy chief physician
PRS Account Tampere University Hospital
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP