Pulmonary EmbolismNCT02597218
Incidence of Venous Thromboembolic Disease and Portal Vein Thrombosis After Hepatectomy. A Cohort Study.
An observational study of Pulmonary Embolism and Venous Thrombosis, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
Observational. Retrospective cohort. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Embolism, Venous Thrombosis, Portal Thrombosis
- How many people
- 350 participants
- Where
- 1 siteArgentina
- Study dates
- Oct 2015to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients older than 18 years following hepatectomy of any kind for oncologic/non-oncologic disease between 04/09/2012 and 08/28/2015 were enrolled. Follow-up concluded 90 days after surgery or at occurence of event (Venous thromboembolism / portal thrombosis / death).
Who may be able to join
- Older than 18 years old.
- Following hepatic surgery.
Who cannot join
- Living donor
- Venous thromboembolism within 6 months previous to surgery.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
Capital Federal, Buenos Aires, 1170
Juan Ignacio Trobbiani, Dr, +542914253231, juaniitrobbiani@gmail.com
About this study
Official title: Incidence of Venous Thromboembolic Disease and Portal Vein Thrombosis After Hepatectomy in a High-volume Center. A Cohort Study.
Observational. Retrospective cohort.
Read the detailed description
Venous thromboembolism (VTE) is a disease that includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). It is a common, potentially lethal disorder that can occur among postoperative patients. Liver surgery implies a prothrombotic state, as a result of an alteration of the equilibrium between synthesis and use of pro and anti coagulant factors after a parenquimal resection. The use of antithrombotic prophylaxis following surgery is not standarized, and current practices vary depending on the attendant surgeon's particular experience or hospital's customs and habits.
In published research, postoperative patients have been studied as a whole so far. There is little evidence regarding patients undergoing hepatectomy. Furthermore, the use and need of extended prophylaxis remains unexplored in this group of patients.
The objetives of the following study are:
- To estimate the incidence of symptomatic venous thromboembolism (VTE) [deep vein thrombosis (DVT), pulmonary embolism (PE) and fatal PE] in a third level center in patients undergoing any hepatectomy within 90 days after surgery.
- To estimate the incidence of portal thrombosis (PT) in a third level center in patients undergoing any hepatectomy within 90 days after surgery.
- To identify and describe factors associated to the development of VTE in patients following hepatectomy.
- To identify and describe factors associated to the development of PT in patients following hepatectomy.
- To describe major bleedings or minor but clinically relevant bleedings during the period in which those patients received chemical thromboprophylaxis.
- Conditions
- Pulmonary Embolism, Venous Thrombosis, Portal Thrombosis
- Keywords
- Hepatectomy, Prophylaxis
- Medical subject headings
- Pulmonary Embolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients following hepatectomy | Patients following hepatectomy of any type, any gender. Roughly, we will describe: type of resection, presence of cancer,use of mechanical/pharmacological prophylaxis, major/minor bleedings ocurring during observation period. Outcomes: Venous thromboembolism (VTE)[deep vein thrombosis (DVT) and pulmonary embolism (PE)] and portal thrombosis (PT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thromboembolism (VTE)
Includes deep vein thrombosis (DVT) and pulmonary embolism (PE)
Measured: 90 days following surgery
Secondary outcomes (3)
Portal Thrombosis (PT)
Portal thrombosis
Measured: 90 days following surgery
Minor bleeding
Any bleeding that doesn't fulfill "major bleeding" criteria.
Measured: 90 days following surgery
Major bleeding
Any bleeding causing: death, serious threat to life, requirement of active medical intervention, 2 or more red blood cell units transfusion, localized in retroperitoneum, intracraneal or intraocular
Measured: 90 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires
- Investigators
- Martín de Santibañes, Dr, Study director, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597218
- Sponsor's protocol ID
- 2611
- Status last verified
- Aug 2019
- First submitted
- 3 Nov 2015
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rasmussen MS. Preventing thromboembolic complications in cancer patients after surgery: a role for prolonged thromboprophylaxis. Cancer Treat Rev. 2002 Jun;28(3):141-4. doi: 10.1016/s0305-7372(02)00043-9.
PubMed 12234565Ejaz A, Spolverato G, Kim Y, Lucas DL, Lau B, Weiss M, Johnston FM, Kheng M, Hirose K, Wolfgang CL, Haut E, Pawlik TM. Defining incidence and risk factors of venous thromboemolism after hepatectomy. J Gastrointest Surg. 2014 Jun;18(6):1116-24. doi: 10.1007/s11605-013-2432-x. Epub 2013 Dec 13.
PubMed 24337986Caprini JA, Arcelus JI, Hasty JH, Tamhane AC, Fabrega F. Clinical assessment of venous thromboembolic risk in surgical patients. Semin Thromb Hemost. 1991;17 Suppl 3:304-12.
PubMed 1754886Collins R, Scrimgeour A, Yusuf S, Peto R. Reduction in fatal pulmonary embolism and venous thrombosis by perioperative administration of subcutaneous heparin. Overview of results of randomized trials in general, orthopedic, and urologic surgery. N Engl J Med. 1988 May 5;318(18):1162-73. doi: 10.1056/NEJM198805053181805. No abstract available.
PubMed 3283548Prevention of fatal postoperative pulmonary embolism by low doses of heparin. An international multicentre trial. Lancet. 1975 Jul 12;2(7924):45-51.
PubMed 49649Kiil J, Kiil J, Axelsen F, Andersen D. Prophylaxis against postoperative pulmonary embolism and deep-vein thrombosis by low-dose heparin. Lancet. 1978 May 27;1(8074):1115-6. doi: 10.1016/s0140-6736(78)90297-0.
PubMed 77413Pezzuoli G, Neri Serneri GG, Settembrini P, Coggi G, Olivari N, Buzzetti G, Chierichetti S, Scotti A, Scatigna M, Carnovali M. Prophylaxis of fatal pulmonary embolism in general surgery using low-molecular weight heparin Cy 216: a multicentre, double-blind, randomized, controlled, clinical trial versus placebo (STEP). STEP-Study Group. Int Surg. 1989 Oct-Dec;74(4):205-10.
PubMed 2560470Mismetti P, Laporte S, Darmon JY, Buchmuller A, Decousus H. Meta-analysis of low molecular weight heparin in the prevention of venous thromboembolism in general surgery. Br J Surg. 2001 Jul;88(7):913-30. doi: 10.1046/j.0007-1323.2001.01800.x.
PubMed 11442521Gould MK, Garcia DA, Wren SM, Karanicolas PJ, Arcelus JI, Heit JA, Samama CM. Prevention of VTE in nonorthopedic surgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e227S-e277S. doi: 10.1378/chest.11-2297.
PubMed 22315263Lyman GH, Khorana AA, Kuderer NM, Lee AY, Arcelus JI, Balaban EP, Clarke JM, Flowers CR, Francis CW, Gates LE, Kakkar AK, Key NS, Levine MN, Liebman HA, Tempero MA, Wong SL, Prestrud AA, Falanga A; American Society of Clinical Oncology Clinical Practice. Venous thromboembolism prophylaxis and treatment in patients with cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2013 Jun 10;31(17):2189-204. doi: 10.1200/JCO.2013.49.1118. Epub 2013 May 13.
PubMed 23669224Barton JS, Riha GM, Differding JA, Underwood SJ, Curren JL, Sheppard BC, Pommier RF, Orloff SL, Schreiber MA, Billingsley KG. Coagulopathy after a liver resection: is it over diagnosed and over treated? HPB (Oxford). 2013 Nov;15(11):865-71. doi: 10.1111/hpb.12051. Epub 2013 Jan 29.
PubMed 23458574Bezeaud A, Denninger MH, Dondero F, Saada V, Venisse L, Huisse MG, Belghiti J, Guillin MC. Hypercoagulability after partial liver resection. Thromb Haemost. 2007 Dec;98(6):1252-6.
PubMed 18064322Tzeng CW, Katz MH, Fleming JB, Pisters PW, Lee JE, Abdalla EK, Curley SA, Vauthey JN, Aloia TA. Risk of venous thromboembolism outweighs post-hepatectomy bleeding complications: analysis of 5651 National Surgical Quality Improvement Program patients. HPB (Oxford). 2012 Aug;14(8):506-13. doi: 10.1111/j.1477-2574.2012.00479.x. Epub 2012 May 15.
PubMed 22762398Smyrniotis V, Farantos C, Kostopanagiotou G, Arkadopoulos N. Vascular control during hepatectomy: review of methods and results. World J Surg. 2005 Nov;29(11):1384-96. doi: 10.1007/s00268-005-0025-x.
PubMed 16222453Yoshiya S, Shirabe K, Nakagawara H, Soejima Y, Yoshizumi T, Ikegami T, Yamashita Y, Harimoto N, Nishie A, Yamanaka T, Maehara Y. Portal vein thrombosis after hepatectomy. World J Surg. 2014 Jun;38(6):1491-7. doi: 10.1007/s00268-013-2440-8.
PubMed 24407940
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Venous Thromboembolic Disease and Portal Vein Thrombosis After Hepatectomy in a High-volume Center. A Cohort Study.
- ClinicalTrials.gov ID
- NCT02597218
- Acronym / sponsor ID
- 2611
- Conditions
- Pulmonary Embolism, Venous Thrombosis, Portal Thrombosis
- Keywords
- Hepatectomy, Prophylaxis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational. Retrospective cohort.
Detailed description
Venous thromboembolism (VTE) is a disease that includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). It is a common, potentially lethal disorder that can occur among postoperative patients. Liver surgery implies a prothrombotic state, as a result of an alteration of the equilibrium between synthesis and use of pro and anti coagulant factors after a parenquimal resection. The use of antithrombotic prophylaxis following surgery is not standarized, and current practices vary depending on the attendant surgeon's particular experience or hospital's customs and habits.
In published research, postoperative patients have been studied as a whole so far. There is little evidence regarding patients undergoing hepatectomy. Furthermore, the use and need of extended prophylaxis remains unexplored in this group of patients.
The objetives of the following study are:
- To estimate the incidence of symptomatic venous thromboembolism (VTE) [deep vein thrombosis (DVT), pulmonary embolism (PE) and fatal PE] in a third level center in patients undergoing any hepatectomy within 90 days after surgery.
- To estimate the incidence of portal thrombosis (PT) in a third level center in patients undergoing any hepatectomy within 90 days after surgery.
- To identify and describe factors associated to the development of VTE in patients following hepatectomy.
- To identify and describe factors associated to the development of PT in patients following hepatectomy.
- To describe major bleedings or minor but clinically relevant bleedings during the period in which those patients received chemical thromboprophylaxis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients following hepatectomy | – | –Patients following hepatectomy of any type, any gender. Roughly, we will describe: type of resection, presence of cancer,use of mechanical/pharmacological prophylaxis, major/minor bleedings ocurring during observation period. Outcomes: Venous thromboembolism (VTE)[deep vein thrombosis (DVT) and pulmonary embolism (PE)] and portal thrombosis (PT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years following hepatectomy of any kind for oncologic/non-oncologic disease between 04/09/2012 and 08/28/2015 were enrolled. Follow-up concluded 90 days after surgery or at occurence of event (Venous thromboembolism / portal thrombosis / death).
Key inclusion criteria (2 listed)
- Older than 18 years old.
- Following hepatic surgery.
Key exclusion criteria (2 listed)
- Living donor
- Venous thromboembolism within 6 months previous to surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Venous thromboembolism (VTE)
Time frame: 90 days following surgery
Includes deep vein thrombosis (DVT) and pulmonary embolism (PE)
3 secondary outcomes
Portal Thrombosis (PT)
Time frame: 90 days following surgery
Minor bleeding
Time frame: 90 days following surgery
Major bleeding
Time frame: 90 days following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Background: PubMed 12234565Rasmussen MS. Preventing thromboembolic complications in cancer patients after surgery: a role for prolonged thromboprophylaxis. Cancer Treat Rev. 2002 Jun;28(3):141-4. doi: 10.1016/s0305-7372(02)00043-9.
- Background: PubMed 24337986Ejaz A, Spolverato G, Kim Y, Lucas DL, Lau B, Weiss M, Johnston FM, Kheng M, Hirose K, Wolfgang CL, Haut E, Pawlik TM. Defining incidence and risk factors of venous thromboemolism after hepatectomy. J Gastrointest Surg. 2014 Jun;18(6):1116-24. doi: 10.1007/s11605-013-2432-x. Epub 2013 Dec 13.
- Background: PubMed 1754886Caprini JA, Arcelus JI, Hasty JH, Tamhane AC, Fabrega F. Clinical assessment of venous thromboembolic risk in surgical patients. Semin Thromb Hemost. 1991;17 Suppl 3:304-12.
- Background: PubMed 3283548Collins R, Scrimgeour A, Yusuf S, Peto R. Reduction in fatal pulmonary embolism and venous thrombosis by perioperative administration of subcutaneous heparin. Overview of results of randomized trials in general, orthopedic, and urologic surgery. N Engl J Med. 1988 May 5;318(18):1162-73. doi: 10.1056/NEJM198805053181805. No abstract available.
- Background: PubMed 49649Prevention of fatal postoperative pulmonary embolism by low doses of heparin. An international multicentre trial. Lancet. 1975 Jul 12;2(7924):45-51.
- Background: PubMed 77413Kiil J, Kiil J, Axelsen F, Andersen D. Prophylaxis against postoperative pulmonary embolism and deep-vein thrombosis by low-dose heparin. Lancet. 1978 May 27;1(8074):1115-6. doi: 10.1016/s0140-6736(78)90297-0.
- Background: PubMed 2560470Pezzuoli G, Neri Serneri GG, Settembrini P, Coggi G, Olivari N, Buzzetti G, Chierichetti S, Scotti A, Scatigna M, Carnovali M. Prophylaxis of fatal pulmonary embolism in general surgery using low-molecular weight heparin Cy 216: a multicentre, double-blind, randomized, controlled, clinical trial versus placebo (STEP). STEP-Study Group. Int Surg. 1989 Oct-Dec;74(4):205-10.
- Background: PubMed 11442521Mismetti P, Laporte S, Darmon JY, Buchmuller A, Decousus H. Meta-analysis of low molecular weight heparin in the prevention of venous thromboembolism in general surgery. Br J Surg. 2001 Jul;88(7):913-30. doi: 10.1046/j.0007-1323.2001.01800.x.
- Background: PubMed 22315263Gould MK, Garcia DA, Wren SM, Karanicolas PJ, Arcelus JI, Heit JA, Samama CM. Prevention of VTE in nonorthopedic surgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e227S-e277S. doi: 10.1378/chest.11-2297.
- Background: PubMed 23669224Lyman GH, Khorana AA, Kuderer NM, Lee AY, Arcelus JI, Balaban EP, Clarke JM, Flowers CR, Francis CW, Gates LE, Kakkar AK, Key NS, Levine MN, Liebman HA, Tempero MA, Wong SL, Prestrud AA, Falanga A; American Society of Clinical Oncology Clinical Practice. Venous thromboembolism prophylaxis and treatment in patients with cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2013 Jun 10;31(17):2189-204. doi: 10.1200/JCO.2013.49.1118. Epub 2013 May 13.
- Background: PubMed 23458574Barton JS, Riha GM, Differding JA, Underwood SJ, Curren JL, Sheppard BC, Pommier RF, Orloff SL, Schreiber MA, Billingsley KG. Coagulopathy after a liver resection: is it over diagnosed and over treated? HPB (Oxford). 2013 Nov;15(11):865-71. doi: 10.1111/hpb.12051. Epub 2013 Jan 29.
- Background: PubMed 18064322Bezeaud A, Denninger MH, Dondero F, Saada V, Venisse L, Huisse MG, Belghiti J, Guillin MC. Hypercoagulability after partial liver resection. Thromb Haemost. 2007 Dec;98(6):1252-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martín de Santibañes, Dr study director
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism and Venous Thrombosis, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Ignacio Trobbiani, Dr (+542914253231, juan.trobbiani@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous thromboembolism (VTE) (time frame: 90 days following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02597218, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.