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van CCT (UK)


The effect of blood clotting and clot reducing medication in blood drawn from patients undergoing liver or pancreas surgery.


- candidate number27074
- NTR NumberNTR6397
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-apr-2017
- Secondary IDs220287 / 17/LO/0527 IRAS project ID / REC reference
- Public TitleThe effect of blood clotting and clot reducing medication in blood drawn from patients undergoing liver or pancreas surgery.
- Scientific TitleThe efficacy of pro- and anticoagulant therapy in plasma of patients undergoing hepatobiliary surgery
- ACRONYM
- hypothesisWe will test the hypothesis that the various drugs have a different effect in blood from patients undergoing liver or pancreas surgery as compared to blood from healthy individuals, and that this effect changes with time, and in doing so aim to identify those agents that can be used with greatest safety and will bring greatest clinical benefit.
- Healt Condition(s) or Problem(s) studiedLiver transplantation, Anticoagulants, Pancreas
- Inclusion criteria- Liver transplantation, right / extended right hepatectomy or pancreatectomy at Kings College Hospital.
- >18 years
- Signed informed consent

Inclusion criteria control group:
- >18 years
- Signed informed consent
- Exclusion criteriaExclusion criteria study group:
- Acute liver failure
- Transplantation for non-cirrhotic liver disease
- Documented history of hereditary thrombophilia
- Use of vitamin K antagonists
- Transfusion of blood products (<7 days)
- Deep vein thrombosis (<30 days)
- HIV positivity

Exclusion criteria control group:
- Documented history of hereditary thrombophilia
- Use of vitamin K antagonists
- Transfusion of blood products (<7 days)
- History of deep vein thrombosis
- Any known form of liver disease
- HIV positivity
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 1-sep-2017
- planned closingdate28-feb-2018
- Target number of participants100
- InterventionsBlood will be drawn at predefined time points, during and after the surgery. During liver transplant surgery, blood will be drawn at 4 time points, while during liver or pancreas resection 2 blood draws are performed in the operating room. Specifically, we will draw 18 ml of blood at the following time points:
A. Liver transplantation:
1. After induction of anesthesia.
2. 30 minutes after the start of the anhepatic phase.
3. 30 minutes after reperfusion.
4. At the end of surgery.
5. 24 hours after the end of surgery.
6. 3 days after the end of surgery.
7. 6 days after the end of surgery.
B. Hepatectomy and pancreatectomy:
1. after induction of anesthesia.
2. At the end of surgery
3. 24 hours after the end of surgery
4. 3 days after the end of surgery
5. 6 days after the end of surgery
In patients in schedule A, samples 1 to 5 and in schedule B samples 1 to 3 will be taken in the operating room or ICU and will not require specific venepuncture as indwelling vascular catheters will be in situ. The remaining 2 blood draws will be conducted on the ward, and where possible will be conducted at the same venipuncture as routine blood sampling.
For the control group, we will recruit healthy volunteers by informative posters in the UMCG and under an existing Netherland ethical approval. In case healthy volunteers are interested in participating, they can contact the PI via the contact information on the informative poster. Applicants will be briefly examined for inclusion and exclusion criteria through a questionnaire filled out by the researcher.
Included volunteers will donate a blood sample of 18 mL obtained through venepunction.
- Primary outcomeThe primary end point of our study is the difference in change of the various parameters of the thrombin generation curve after in vitro addition of a fixed dose of a pro- or anticoagulant drug between patient and control samples. This degree of change indicates the pro- or anticoagulant efficacy of a certain drug as described previously. (Potze W, et al.
Differential in vitro inhibition of thrombin generation by anticoagulant drugs in plasma from patients with cirrhosis. (PLoS One 2014 Feb 4;9(2):e88390)
- Secondary outcomeWe do not have any secondary outcome measures, but will assess several other laboratory parameters which we will use to describe the cohort such as the individual coagulation factors, PT, INR, APTT, Fibrinogen, Platelet count and Hb. Indicators of liver function such as GGT, ALT, AST, NH3, alpha1 antitrypsin and ceruloplasmin.
- TimepointsEthical approval is under consideration. Planned starting date of inclusion is 01/09/2017
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD S. Bos
- CONTACT for SCIENTIFIC QUERIESDr. William Bernal
- Sponsor/Initiator King's College London, Guy's & St Thomas' NHS Foundation Trust
- Funding
(Source(s) of Monetary or Material Support)
Research Training Award
- PublicationsN/A
- Brief summaryThe liver is central to the process of 'haemostasis', the process that enables blood to clot. Amongst its important functions are the synthesis of both pro- and anti-coagulant substances. Major hepatobiliary surgery is associated with complications that may include both intraoperative bleeding and postoperative thromboembolism, including deep vein thrombosis and pulmonary embolism. These complications may result in both morbidity and mortality; their risk increases with the extent of the procedure. Pre-operative prediction is difficult as risk of bleeding and thrombosis is not well reflected by conventional hemostasis tests such as the prothrombin time and platelet count. More advanced hemostasis testing, for example by newer assays such as 'thrombomodulin-modified thrombin generation' testing, is consistent with a post-operative hyper-coagulable state in many cases.
Hemostatic profiles during and after liver surgery have been recently studied in detail using these assays. However, little clinical is available on the efficacy and safety of pro- and anti-hemostatic drugs used in patients identified as being at risk.
We aim to assess the in vitro efficacy of both pro- and anticoagulant drugs by comparing thrombin generation curves generated in plasma taken from patients during and after liver and hepatobiliary surgery and with thrombin generation curves generated in the plasma of healthy volunteers. Various pro- and anti-coagulant drugs will be added to these plasma samples in vitro. The change in parameters of the thrombin generation curve after addition of pro- or anticoagulant drug will be evaluated. This study may help identify those drugs most effective in this setting and guide their dosage in patients during and after liver surgery.
- Main changes (audit trail)
- RECORD11-apr-2017 - 21-jun-2017


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