Blood Loss, Surgical Clinical Trial
— ROTEM-SUROfficial title:
ROTEM-guided Transfusion Protocol Versus Standard Care in Attempt to Reduce Blood Transfusions in Potentially Curative Major Abdominal and Urological Oncological Surgery
NCT number | NCT03993977 |
Other study ID # | ETL R17025 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2020 |
Est. completion date | October 13, 2020 |
Verified date | December 2020 |
Source | Tampere University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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). |
Country | Name | City | State |
---|---|---|---|
Finland | Tampere University Hospital | Tampere |
Lead Sponsor | Collaborator |
---|---|
Tampere University Hospital |
Finland,
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 |
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