Correction of sub-clinical prolongation of COAGulation tests and/or low platelets before TRACHeotomy: randomised controlled trial

ISRCTN	ISRCTN31808827
DOI	https://doi.org/10.1186/ISRCTN31808827
Secondary identifying numbers	NTR694

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr D.P Veelo
Scientific

Academic Medical Center
Department of Intensive Care
Meibergdreef 5
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 5666345
Email	d.p.veelo@amc.uva.nl

Study design	Randomised, single blinded, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	The COAG-TRACH study
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
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 study start date	01/07/2006
Completion date	01/07/2009

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	152
Key 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
Key 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
Date of first enrolment	01/07/2006
Date of final enrolment	01/07/2009

Academic Medical Center

Amsterdam
1105 AZ
Netherlands

Academic Medical Centre (AMC) (The Netherlands) - Department of Intensive Care
University/education

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website	http://www.amc.uva.nl
"ROR"	https://ror.org/03t4gr691

Hospital/treatment centre

Academic Medical Centre (AMC) (The Netherlands) - Department of Intensive Care

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2012		Yes	No