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Clinical Trial Details — Status: Withdrawn

Administrative data

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Status Withdrawn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

Study information

Verified date December 2020
Source Tampere University Hospital
Contact n/a
Is FDA regulated No
Health authority
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Status Withdrawn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).

Study Design


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
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