Condition category
Surgery
Date applied
19/07/2006
Date assigned
19/07/2006
Last edited
02/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.amc.uva.nl

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22337277

Publication citations

  1. 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.

Additional files

Editorial Notes