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出境医 / 临床实验 / ROTEM-guided Transfusion Protocol in Attempt to Reduce Blood Transfusions in Major Oncological Surgery (ROTEM-SUR)
ROTEM-guided Transfusion Protocol in Attempt to Reduce Blood Transfusions in Major Oncological Surgery (ROTEM-SUR)
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Blood Loss, Surgical Blood Loss Requiring Transfusion Coagulation Defect; Acquired | Diagnostic Test: Rotational thromboelastometry Other: Conventional treatment | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| 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 |
| Official Title: | ROTEM-guided Transfusion Protocol Versus Standard Care in Attempt to Reduce Blood Transfusions in Potentially Curative Major Abdominal and Urological Oncological Surgery |
| Estimated Study Start Date : | May 1, 2020 |
| Actual Primary Completion Date : | October 13, 2020 |
| Actual Study Completion Date : | October 13, 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: ROTEM-arm
Treatment of significant blood loss using point-of-care testing of whole blood viscoelasticity (ROTEM) monitoring coagulopathy or hyperfibrinolysis.
|
Diagnostic Test: Rotational thromboelastometry
ROTEM-guided protocol of hemostatic resuscitation
Other Name: ROTEM
|
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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).
|
Other: Conventional treatment
Clinical judgement and conventional coagulation tests
|
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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
Other Outcome Measures:
- Signs of altered coagulation [ Time Frame: 12-24 hours after surgery ]Possible signs hypercoagulopathy in thromboelastometry: EXTEM value of more than 72 mm
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
Locations
| Finland | |
| Tampere University Hospital | |
| Tampere, Finland, 33560 | |
Sponsors and Collaborators
Tampere University Hospital
Investigators
| Study Director: | Anne Kuitunen, MD, PhD | Deputy chief physician |
| 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 |
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
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| Original Primary Outcome Measures ICMJE |
Number of transfused red blood cell (RBC) units [ Time Frame: 24 hours after beginning of surgery ] | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures |
Signs of altered coagulation [ Time Frame: 12-24 hours after surgery ] Possible signs hypercoagulopathy in thromboelastometry: EXTEM value of more than 72 mm
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| 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
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Actual Enrollment ICMJE |
0 | ||||
| Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Tampere University Hospital | ||||
| Study Sponsor ICMJE | Tampere University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Tampere University Hospital | ||||
| Verification Date | December 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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