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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21788

Enrollment

152

Registered

2006-05-29

Start date

2006-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICU-patients with sub-clinical lengthening of coagulation tests (PTT 14.7 – 20 seconds, platelets < 100 x 109/L) or the use of Ascal® planned for percutaneous tracheotomy

Interventions

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.

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

Measure	Time frame
The volume of blood loss during PDT. The intensity of intra-tracheal bleeding. Time until no blood is visible in tracheal aspirates.	—

Secondary

Measure	Time frame
The amount of bloodproducts used during and after tracheotomy.	—

Contacts

Public ContactD.P Veelo

Academic Medical Center, Departement of Intensive Care, Meibergdreef 5,

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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)