Contact information
Type
Scientific
Primary contact
Dr D.P Veelo
ORCID ID
Contact details
Academic Medical Center
Department of Intensive Care
Meibergdreef 5
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5666345
d.p.veelo@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR694
Study information
Scientific title
Acronym
The COAG-TRACH study
Study hypothesis
Correction of sub-clinical prolongation of coagulation tests (i.e. partial thromboplastin time [PTT] between 14.7 - 20 seconds and platelets less than 100 x 10^9/l) and transfusion of platelets in patients taking Ascal®, significantly decreases the incidence of clinically significant peri-procedural bleeding.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, single blinded, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Blood coagulation disorders, percutaneous tracheotomy (PDT)
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.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
1. The volume of blood loss during PDT
2. The intensity of intra-tracheal bleeding
3. Time until no blood is visible in tracheal aspirates
Secondary outcome measures
The amount of blood products used during and after tracheotomy
Overall trial start date
01/07/2006
Overall trial end date
01/07/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Sub-clinical lengthening of coagulation
2. Tests and/or low platelets
3. Use of Ascal®
4. Planned percutaneous tracheotomy (PDT)
5. Aged greater than 18 years
6. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
152
Participant exclusion criteria
1. Contraindications for percutaneous tracheotomy (PDT) (i.e. surgical tracheotomy is preferred)
2. Contraindications for transfusion of blood products
3. Contraindication for correction of coagulation disorders
4. PTT greater than 20 seconds
5. Use of clopidogrel
Recruitment start date
01/07/2006
Recruitment end date
01/07/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands) - Department of Intensive Care
Sponsor details
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Centre (AMC) (The Netherlands) - Department of Intensive Care
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22337277
Publication citations
-
Results
Veelo DP, Vlaar AP, Dongelmans DA, Binnekade JM, Levi M, Paulus F, Berends F, Schultz MJ, Correction of subclinical coagulation disorders before percutaneous dilatational tracheotomy., Blood Transfus, 2012, 10, 2, 213-220, doi: 10.2450/2012.0086-11.