A Randomised Controlled Trial to Compare Administration of Prothrombin Complex Concentrate with Standard Haemostasis Management in Adult Patients Undergoing Peritoneal Cytoreductive Surgery Requiring Massive Transfusion.

Efficacy of prothrombin complex in achieving haemostasis compared to standard treatment in adult patients undergoing peritoneal cytoreductive surgery requiring massive transfusion.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001002875

Enrollment

Registered

2012-09-18

Start date

2013-10-08

Completion date

2017-02-28

Last updated

2021-01-05

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

Conditions

None listed

Brief summary

The purpose of this study is to investigate whether the early use of a blood clotting drug during peritonectomy surgery reduces the amount of bleeding that occurs and so reduces the amount of blood transfusion you may need. Who is it for? You may be eligible to join this study if you are aged 18 years or above and are scheduled to undergo a peritonectomy. Trial details: Peritonectomy surgery is associated with a high risk of bleeding and many patients will require what is known as massive blood transfusion. This typically involves a transfusion of at least 10 units of blood or roughly your whole blood volume. In this research we hope to compare two treatments. Half the participants will receive the standard treatment used in this hospital. This involves the use of blood clotting factors and blood transfusion. In addition patients who have persistently high blood loss are sometimes given a treatment called recombinant factor VIIa. The other half of the participants will receive a product known as Prothrombinex-VF early in the operation when the anaesthetist suspects that there will be high blood loss. Prothrombinex-VF is a commercial product that contains blood clotting factors – these help the blood clot. All other treatment will be the same as usual practice. With this research we hope to be able to show that early use of Prothrombinex-VF reduces the need for blood transfusion and the overall need for blood products such as blood clotting factor preparations.

Interventions

Patients to receive early administration of prothrombin complex concentrate. It may be administered after surgery has commenced and based on the peritoneal carcinomatosis index (PCI) count, it is considered that the patient is at high risk of massive transfusion. Prothrombinex will be administered at a dose of 20IU/kg ( up to a maximum of 50IU/kg), given intravenously. The dose given will be at the discretion of the physician.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age greater than or equal to 18 years 2. Planned for peritonectomy 3. Informed consent

Exclusion criteria

1. Known bleeding disorder 2. Known requirement for anti-coagulation e.g. prior DVT/PE requiring anti-coagulation, requirement for caval filter 3. Known hypersensitivity to any pooled-blood or recombinant blood products 4. Known hypersensitivity to any constituents in Prothrombinex-VF, including know allergy to heparin or a history of heparin-induced thrombocytopenia 5. Evidence of active thrombosis or disseminated intravascular coagulation (DIC)

Outcome results