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The purpose of this study is to compare two different thromboelastometry (ROTEM) trigger levels for administration of human fibrinogen concentrate (Haemocomplettan P) in the treatment of perioperative dilutional coagulopathy during major pediatric surgery. The study hypothesis is that administration of fibrinogen concentrate triggered by a ROTEM FibTEM MCF < 13 mm might reduce the total amount of transfused red cell concentrate during 24 hours after start of surgery as compared to a trigger level of ROTEM FibTEM MCF < 8 mm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrinogen if FibTEM < 8 mm | Active Comparator | Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF < 8 mm |
|
| Fibrinogen if FibTEM < 13 mm | Experimental | Administration of fibrinogen concentrate if ROTEM FibTEM revealed MCF < 13 mm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human fibrinogen concentrate | Drug | Administration of human fibrinogen concentrate (30 mg / kg bw) over 15 min Repetition if hourly intraoperative ROTEM measurements revealed hypofibrinogenemia according to treatment group definition |
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of transfused red cell concentrate | 24 hours after start of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| coagulation measurements | influence on viscoelastic coagulation measurements (ROTEM), plasmatic coagulation testing, FXIII levels, and endogenous thrombin potential | 24 hours after start of surgery |
| length of stay on PICU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thorsten Haas, MD | Zurich University Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zurich University Children's Hospital | Zurich | 8032 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34215519 | Derived | Restin T, Schmugge M, Cushing MM, Haas T. Comparison between intraoperative bleeding score and ROTEM(R) measurements to assess coagulopathy during major pediatric surgery. Transfus Apher Sci. 2021 Oct;60(5):103191. doi: 10.1016/j.transci.2021.103191. Epub 2021 Jun 19. | |
| 25982134 | Derived | Haas T, Spielmann N, Restin T, Seifert B, Henze G, Obwegeser J, Min K, Jeszenszky D, Weiss M, Schmugge M. Higher fibrinogen concentrations for reduction of transfusion requirements during major paediatric surgery: A prospective randomised controlled trial. Br J Anaesth. 2015 Aug;115(2):234-43. doi: 10.1093/bja/aev136. Epub 2015 May 15. |
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| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006470 | Hemorrhage |
| D019106 | Postoperative Hemorrhage |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 14 days after surgery or discharge of hospital, whatever occurs earlier |
| Additional transfusion/blood products requirements | 24 hours after start of surgery |
| Occurence of re-bleeding, surgical revision | 14 days after surgery or discharge of hospital, whatever occurs earlier |
| Occurence of (severe) adverse events | 14 days after surgery or discharge of hospital, whatever occurs earlier |
| D011183 | Postoperative Complications |