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Whole blood thrombin generation test- a clinical validation

Clinical validation of the whole blood thrombin generation assay

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON25031
Enrollment
60
Registered
2013-11-08
Start date
2013-11-11
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

non-cardiac surgery (niet cardiale chirurgie), bleeding (bloeding), haemostasis (haemostase)

Interventions

Patients with controlled bleeding due to non cardiac surgery will receive standard treatment with blood products according to local protocols.

Sponsors

Maastricht University Medical Center and Synapse b.v. (CARIM) Oxfordlaan 70 6229EV Maastricht
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing major surgery (major abdominal surgery, aorta aneurysms, major orthopaedic surgery) that have a greater chance to develop a bleeding will be asked to participate to our study. Patient inclusion will only occur when they are suffering from a bleeding during/after major surgery receiving a transfusion of blood products and/or factor concentrates.

Exclusion criteria

Exclusion criteria: age below 18 years. Patients with acute life-threatening bleeding. Patients undergoing cardiothoracic or vascular surgery receiving heparintherapy

Design outcomes

Primary

MeasureTime frame
Whole blood measeurement before and after treatment compared to standard plasma thrombin generation

Secondary

MeasureTime frame
parameters of clinical bleeding (transfusion after the second test, fluid substitution)

Contacts

Public ContactM.D. Lancé

dept of anesthesiology MUMC+ P.Debeyelaan 25

marcus.lance@mumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)