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| Name | Class |
|---|---|
| Academy of Finland | OTHER |
| The Finnish Medical Association | OTHER |
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Thromboprophylaxis for liver surgery can be commenced either preoperatively or postoperatively. Despite a clear trade-off between thrombosis and bleeding in liver surgery patients, there is no international consensus when thrombosis prophylaxis should be commenced in patients undergoing liver surgery. As far as we know, there are no prospective randomized trials in this field, and current guidelines are unfortunately based on very low quality evidence, that is, a few retrospective studies and expert opinion. Both American and European thromboprophylaxis guidelines for abdominal cancer surgery support the preoperative initiation of thromboprophylaxis, but these guidelines do not specifically address the increased bleeding risk associated with liver surgery. On the contrary, Dutch guidelines recommend postoperative thromboprophylaxis only, because of lack of evidence for preoperative thromboprophylaxis. Traditionally, many liver surgery units have been reluctant in using preoperative thromboprophylaxis due to the potentially increased risk of bleeding complications. Enhanced Recovery After Surgery (ERAS) Society Guidelines recommend preoperative thromboprophylaxis in liver surgery, but the guidelines provide no supporting evidence for this recommendation. Overall, the amount of evidence is scarce and somewhat contradictory in this clinically relevant field of thromboprophylaxis in liver surgery. The aim of this study is to compare pre- and postoperatively initiated thromboprophylaxis regimens in liver surgery in a randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative thromboprophylaxis | Experimental | Preoperatively initiated tromboprophylaxis |
|
| Postoperative thromboprophylaxis | Other | Postoperatively initiated thromboprophylaxis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enoxaparin or tinzaparin or dalteparin | Drug | Thromboprophylaxis initiated approximately 14 hours prior to the planned liver resection skin incision. Thromboprophylaxis can be initiated using enoxaparin (20 - 40 mg), tinzaparin (2500 - 4500 IU), or dalteparin (2500 - 5000 IU), with the dose based on patient's renal function |
| Measure | Description | Time Frame |
|---|---|---|
| Venous thromboembolisms | Number of patients with venous thromboembolism defined as either 1) symptomatic deep venous thromboembolism (includes all deep veins e.g. all extremities, portal vein, and superior mesenteric) diagnosed using ultrasound or computed tomography or magnetic resonance imaging, or in re-laparatomy/surgery, 2) pulmonary embolism diagnosed using computed tomography, magnetic resonance imaging, or lung perfusion imaging, or 3) death due to venous thromboembolism | within 30 days from liver resection |
| Measure | Description | Time Frame |
|---|---|---|
| Posthepatectomy haemorrhage | Number of patients with posthepatectomy haemorrhage, any grade in ISGLS classification | within 30 days from liver resection |
| Postoperative complications | Comprehensive Complication Index - score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ville Sallinen, MD, PhD | Contact | +358-9-4711 | ville.sallinen@helsinki.fi |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Recruiting | Helsinki | Finland |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| D000078222 | Tinzaparin |
| D017985 | Dalteparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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|
| No intervention | Drug | No preoperative thromboprophylaxis. |
|
| within 30 days from liver resection |
| Length of postoperative hospital stay | Length of postoperative hospital stay, days | within 30 days from liver resection |
| Blood transfusion | Total amount of transfused red blood cells, units | during and within 30 days from liver resection |
| Kuopio University Hospital | Recruiting | Kuopio | Finland |
|
| Oulu University Hospital | Not yet recruiting | Oulu | Finland |
|
| Tampere University Hospital | Recruiting | Tampere | Finland |
|
| Turku University Hospital | Not yet recruiting | Turku | Finland |
|
| Oslo University Hospital | Recruiting | Oslo | Norway |
|
| University Hospital of North Norway | Recruiting | Tromsø | Norway |
|
| D008107 |
| Liver Diseases |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002241 |
| Carbohydrates |