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 |
| Protocol serial number | NTR694 |
| Sponsor | Academic Medical Centre (AMC) (The Netherlands) - Department of Intensive Care |
| Funder | Academic Medical Centre (AMC) (The Netherlands) - Department of Intensive Care |
- Submission date
- 19/07/2006
- Registration date
- 19/07/2006
- Last edited
- 02/08/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr D.P Veelo
Scientific
Scientific
Academic Medical Center
Department of Intensive Care
Meibergdreef 5
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 5666345 |
|---|---|
| d.p.veelo@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, single blinded, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. The volume of blood loss during PDT |
| Key secondary outcome measure(s) |
The amount of blood products used during and after tracheotomy |
| Completion date | 01/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2012 | Yes | No |
