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van CCT (UK)


Correction of Sub-clinical Prolongation of COAGulation Tests and/or Low Platelets before TRACHeotomy. (Randomized controlled trial).


- candidate number2107
- NTR NumberNTR694
- ISRCTNISRCTN31808827
- Date ISRCTN created19-jul-2006
- date ISRCTN requested4-jul-2006
- Date Registered NTR29-mei-2006
- Secondary IDsN/A 
- Public TitleCorrection of Sub-clinical Prolongation of COAGulation Tests and/or Low Platelets before TRACHeotomy. (Randomized controlled trial).
- Scientific TitleCorrection of Sub-clinical Prolongation of COAGulation Tests and/or Low Platelets before TRACHeotomy. (Randomized controlled trial).
- ACRONYMThe COAG-TRACH study.
- hypothesisCorrection of sub-clinical prolongation of coagulation tests (i.e., PTT between 14.7 – 20 seconds and platelets < 100 x 109/L) and transfusion of platelets in patients with Ascal®, significantly decreases the incidence of clinical significant peri-procedural bleeding.
- Healt Condition(s) or Problem(s) studiedBlood coagulation, Percutaneous tracheotomy (PDT)
- Inclusion criteria1. Sub-clinical lengthening of coagulation; 2. Tests and or low platelets; 3. Use of Ascal; 4. Planned PDT; 5. Age > 18 years; 6. Informed consent.
- Exclusion criteria1. Contraindication for PDT (i.e., surgical tracheotomy is preferred); 2. Contra-indications for transfusion of blood products; 3. Contra-indication for correction of coagulation disorders; 4. PTT > 20 seconds; 5. Use of clopidogrel.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jul-2006
- planned closingdate1-jul-2009
- Target number of participants152
- InterventionsIn group 1 patients receive platelets and/or plasma before PDT until normal values are reached. In group 2 patients do not receive platelets and/or plasma.
- Primary outcomeThe volume of blood loss during PDT. The intensity of intra-tracheal bleeding. Time until no blood is visible in tracheal aspirates.
- Secondary outcomeThe amount of bloodproducts used during and after tracheotomy.
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES D.P Veelo
- CONTACT for SCIENTIFIC QUERIESProf. Dr. M.J. Schultz
- Sponsor/Initiator Academic Medical Center (AMC), Department of Intensive Care
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Intensive Care
- Publications1) Kollef MH, Ahrens TS, Shannon W. Clinical predictors and outcomes for patients requiring tracheostomy in the intensive care unit. Crit Care Med 1999:27:1714-1720.; 2) Esteban A, Anzueto A, Alia I, Gordo F, Apezteguia C, Palizas F, Cide D, Goldwaser R, Soto L, Bugedo G, Rodrigo C, Pimentel J, Raimondi G, Tobin MJ. How is mechanical ventilation employed in the intensive care unit? An international utilization review. Am J Respir Crit Care Med 2000:161:1450-1458.; 3) Fischler L, Erhart S, Kleger GR, Frutiger A. Prevalence of tracheostomy in ICU patients. A nation-wide survey in Switzerland. Intensive Care Med 2000:26:1428-1433; 4) Frutos-Vivar F, Esteban A, Apezteguia C, Anzueto A, Nightingale P, Gonzalez M, Soto L, Rodrigo C, Raad J, David CM, Matamis D, G DE. Outcome of mechanically ventilated patients who require a tracheostomy. Crit Care Med 2005:33:290-298.; 5) Rodriguez JL, Steinberg SM, Luchetti FA, Gibbons KJ, Taheri PA, Flint LM. Early tracheostomy for primary airway management in the surgical critical care setting. Surgery 1990:108:655-659; 6) Heffner JE. Medical indications for tracheotomy. Chest 1989:96:186-190; 7) Marsh HM, Gillespie DJ, Baumgartner AE. Timing of tracheostomy in the critically ill patient. Chest 1989:96:190-193; 8) Heffner JE, Miller KS, Sahn SA. Tracheostomy in the intensive care unit. Part 1: Indications, technique, management. Chest 1986:90:269-274; 9) Heffner JE, Miller KS, Sahn SA. Tracheostomy in the intensive care unit. Part 2: Complications. Chest 1986:90:430-436; 10) Griffiths J, Barber VS, Morgan L, Young JD. Systematic review and meta-analysis of studies of the timing of tracheostomy in adult patients undergoing artificial ventilation. Bmj 2005:330:1243; 11) Dongelmans DA, van der Lely AJ, Tepaske R, Schultz MJ. Complications of percutaneous dilating tracheostomy. Crit Care 2004:8:397-398; author reply 397-398; 12) Fikkers BG, Staatsen M, Lardenoije SG, van den Hoogen FJ, van der Hoeven JG. Comparison of two percutaneous tracheostomy techniques, guide wire dilating forceps and Ciaglia Blue Rhino: a sequential cohort study. Crit Care 2004:8:R299-305; 13) Gajic O, Moore SB. Transfusion-related acute lung injury. Mayo Clin Proc 2005:80:766-770.
- Brief summaryBackground of the study: Percutaneous dilational tracheotomy (PDT) is increasingly performed in mechanically ventilated intensive care unit (ICU)–patients. One of the complications of PDT, however, is peri-procedural bleeding, although the risk is normally very low. A large majority of ICU–patients demonstrate abnormalities in the coagulation system, varying from sub-clinical prolongation of coagulation tests and/or low platelets, to more severe coagulation disorders, better known as disseminated intravascular coagulation (DIC). For prolongation of coagulation tests (PTT > 20 seconds) and low platelets (platelets < 50 x 10e9/L), usually plasma and platelet concentrates are transfused before tracheotomy is performed. There are no clear guidelines on prolongation of PTT > 14.7 seconds, platelets < 100 x 10e9/L and patients using Ascal. Transfusion of blood products bears the risk of transmission of infectious diseases. In addition, the use of plasma products increases the risk of transfusion-associated acute lung injury (TRALI). Furthermore, it is uncertain whether plasma and/or platelets transfusion truly influences the risk of bleeding in patients with sub-clinical prolongation of coagulation tests and low platelets during PDT Objective of the study: To determine if patients with sub-clinical lengthening of coagulation test, low platelets or use of Ascal have increased risk of clinical significant bleeding during and after tracheotomy. Study design: Randomized controlled trial Study population: ICU-patients, older than 18 years, with sub-clinical lengthening of coagulation tests (PTT 14.7 – 20 seconds, platelets < 100 x 10e9/L) or the use of Ascal who recieve a tracheotomy Intervention: In group 1 patients receive platelets and/or plasma before PDT until normal values are reached. In group 2 patients do not receive platelets and/or plasma. Primary study parameters/outcome of the study: the volume of blood loss during PDT the intensity of intra-tracheal bleeding time until no blood is visible in tracheal aspirates Secundary study parameters/outcome of the study (if applicable): The amount of bloodproducts used during and after tracheotomy Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable): All interventions are part of the standard care surrounding patients that recieve tracheotomy. Therefore the extent of the burden should be regarded as small. Bloodproducts will be available for immediate administration during PDT, if necessary to decrease the risk of bleeding.
- Main changes (audit trail)
- RECORD29-mei-2006 - 20-jul-2006


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