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

The efficacy of pro- and anticoagulant therapy in plasma of patients undergoing hepatobiliary surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
NL-OMON
Registry ID
NL-OMON28973
Enrollment
100
Registered
2017-04-11
Start date
2017-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver tranplantation, partial hepatectomy, pancreatectomy, cirrhosis, anticoagulation, procoagulants

Interventions

Blood 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 dra

Sponsors

Kings College Hospital NHS Foundation Trust
Lead Sponsor

Eligibility

Inclusion criteria

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 criteria

Exclusion criteria: Exclusion 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

Design outcomes

Primary

MeasureTime frame
The 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&#894;9(2):e88390)

Secondary

MeasureTime frame
We 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.

Contacts

Public ContactS. Bos

Hanzeplein 1

s.bos01@umcg.nltelephone nr: +31503610097

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)