RecruitingACTRN12612000691842

Dynamic changes in clot formation using Thromboelastometry after reinfusion of unwashed cell salvaged whole blood in total hip arthroplasty: a pilot study

Dynamic changes in clot formation using Thromboelastometry after reinfusion of unwashed cell salvaged whole blood in total hip arthroplasty


Sponsor

Astra Tech AB

Enrollment

25 participants

Start Date

Jun 8, 2011

Study Type

Interventional

Conditions

Summary

A pilot study: As part of our standard care, in line with a comprehensive blood management approach, patients presenting for primary hip arthroplasty are offered intra-operative cell salvage. One type of cell saver used is the SANGVIA system. Blood is collected during surgery, filtered and can be reinfused post-operatively. This is a relatively new technology and there is some controversy around the efficacy, safety and potential adverse effects of the reinfusion. This includes some concern whether a coagulopathy might be induced by reinfusion through various mechamisms. of cytokines. A "point of care device" "ROTEM" is well established in clinical medicine. It is comprehensive diagnostic system coagulation management. We would like to assess the patients' clotting profile before incision and the potential impact of reinfusion of the salvaged blood at the end of the operation. This will be conducted with ROTEM , testing for ex-TEM S (screening extrinsic clotting pathway & platelet contribution to clot formation), in-TEM S (screening intrinsic clotting pathway & platelet contribution to clot formation)compared to standard Lab testing (INR, aPTT). A small sample volume of the shed blood is collected and analyed for haemoglobin and platelets to assess the quality and composition of the blood. In addition a 2nd sample is frozen which will be analyzed after completion of the study to assess the presence and levels of imflammatory mediators.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This is a small pilot study for patients having hip replacement surgery. During surgery, some blood is collected, filtered, and given back to the patient afterward to reduce the need for donated blood. This study uses a monitoring device called ROTEM to check whether this process affects the blood's ability to clot normally. Results will help doctors better understand the safety of this blood-saving technique. You may be eligible if: - You are 18 years or older - You are having your first hip replacement surgery You may NOT be eligible if: - There are medical reasons you cannot receive your own collected blood back - You refuse the procedure - You have an existing blood clotting disorder Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

to evaluate if the reinfusion of cellsalvaged whole blood will impact on coagulation observed in standard laboratory testing and/or thrombelasometry. A minimum of 300ml blood is collected during hip r

to evaluate if the reinfusion of cellsalvaged whole blood will impact on coagulation observed in standard laboratory testing and/or thrombelasometry. A minimum of 300ml blood is collected during hip replacement surgery using the SANGVIA cell saver system, filtered and then reinfused immediately post-operatively


Locations(1)

Australia

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