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In order to reduce bloodloss and need for transfusion to investigate the effect of colloid and crystalloid on coagulation assuming no difference between the groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| crystalloid | Active Comparator |
| |
| colloid | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ringer-lactate "SAD" | Drug | Lactated Ringer's is administrated intravenously in the dosis of max. 35 ml/kg during the operation after securing normovolaemia with Nexfin Monitor at induction of the anaesthesia: if bolus infusion of 200 ml increases stroke volume more than 10 % the patient is not assumed normovolaemic and bolus infusions are repeated until normovolaemic status is achieved. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of colloid versus crystalloid on laboratory coagulation. | Coagulation is analysed in bloodsamples before, during (10 minutes post cystectomia), at the end of the operation and 2 hours later on. The bloodsamples are analysed by thromboelastography (5000 series TEG analyzer, Haemoscope Corporation, Niles IL, USA) besides the classic coagulation parametres: platelet count, INR, Fibrinogen, APTT, D-dimer and Haemoglobin, Amylase and Creatinin. | 5-7 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of colloid versus crystalloid on the amount of bloodloss | The water balance inclusive the amount of bloodloss is registrated at the end of the operation and 2 hours later on. | 5-7 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Niels H Secher, Professor | Contact | +45 3545 2242 | nielsh.secher@rh.regionh.dk | |
| Kirsten C Rasmussen, MD | Contact | +45 61335239 | +45 35458735 | dockcr@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24100337 | Derived | Rasmussen KC, Johansson PI, Hojskov M, Kridina I, Kistorp T, Thind P, Nielsen HB, Ruhnau B, Pedersen T, Secher NH. Hydroxyethyl starch reduces coagulation competence and increases blood loss during major surgery: results from a randomized controlled trial. Ann Surg. 2014 Feb;259(2):249-54. doi: 10.1097/SLA.0000000000000267. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 28, 2015 | |
| Reset | Jan 29, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 28, 2015 | Jan 29, 2016 |
| ID | Term |
|---|---|
| C485123 | HES 130-0.4 |
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| HES 130/04 | Drug | Voluven is administered intravenously in the doses of max. 35 ml/kg during the operation. Normovolaemia is achieved in the same way as described in intervention by Ringer-lactate "SAD". |
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