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The purpose of this study is to find out, whether filtration of the blood in patients undergoing cardiac surgery, beneficially influences the coagulation system.
The impact of modified ultrafiltration following extracorporeal circulation on primary and secondary hemostasis is controversial. In this study we intend to assess both, primary and secondary hemostasis prior to and after the usage of modified ultrafiltration. Primary hemostasis is assessed using Multiple Electrode Aggregometry (Multiplate) and secondary hemostasis is assessed performing thrombelastometry using the ROTEM device. Patients are preoperatively randomized to receive either modified ultrafiltration or no filtration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| with modified ultrafiltration | elective cardiac surgery patients undergoing complex surgical intervention: coronary artery bypass grafting AND valve surgery double valve surgery aortic surgery Re-Dos |
| |
| without modified ultrafiltration | elective cardiac surgery patients undergoing complex surgical intervention: coronary artery bypass grafting AND valve surgery double valve surgery aortic surgery Re-Dos |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified ultrafiltration using Maquet haemoconcentrator, BC 20 plus | Device | usage of modified ultrafiltration following extracorporeal circulation; filtration about 1,5 liters and re-fill with colloids |
| Measure | Description | Time Frame |
|---|---|---|
| ex vivo platelet aggregation (TRAPtest) | 20 min after filtration |
| Measure | Description | Time Frame |
|---|---|---|
| secondary hemostasis assessed by ROTEM | 20 min before and after filtration | |
| blood loss | 24 h after filtration | |
| kind and number of transfused blood products |
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Inclusion Criteria:
Exclusion Criteria:
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electice cardiac surgery patients undergoing complex procedures: CABG and valve double-valve aortic surgery Re-Dos
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| Name | Affiliation | Role |
|---|---|---|
| Christian F Weber, Dr. | Goethe University Frankfurt, Clinic for Anaesthesiology, Theodor Stern Kai 7, 60590 Frankfurt am Main, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goethe University hospital, Clinic for Anaesthesioloy | Frankfurt am Main | 60590 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17046273 | Background | Boodhwani M, Williams K, Babaev A, Gill G, Saleem N, Rubens FD. Ultrafiltration reduces blood transfusions following cardiac surgery: A meta-analysis. Eur J Cardiothorac Surg. 2006 Dec;30(6):892-7. doi: 10.1016/j.ejcts.2006.09.014. Epub 2006 Oct 13. | |
| 21130474 | Derived | Weber CF, Jambor C, Strasser C, Moritz A, Papadopoulos N, Zacharowski K, Meininger D. Normovolemic modified ultrafiltration is associated with better preserved platelet function and less postoperative blood loss in patients undergoing complex cardiac surgery: a randomized and controlled study. J Thorac Cardiovasc Surg. 2011 May;141(5):1298-304. doi: 10.1016/j.jtcvs.2010.09.057. Epub 2010 Dec 3. |
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| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
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|
| 24h after filtration |
| conventional coagulation analyses (INR, aPTT, platelet count, fibrinogen concentration) | 20 min before and after filtration |
| rate of rethoracotomy for bleeding | 24h after filtration |
| D006425 |
| Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |