Trial Outcomes & Findings for Heparin Dose and Post Operative Bleeding in Cardiopulmonary Bypass Patients (NCT NCT01574105)

Results Overview

Chest tube losses will be measured in millilitres upon arrival in the Intensive Care unit (ICU) after six hours in the ICU and total chest tube losses during the ICU stay. Chest tube losses are the amount of blood collected in a graduated chest tube collection reservoir from chest tubes placed in the patient's chest wound at the end of surgery.

Recruitment status

COMPLETED

Target enrollment

66 participants

Primary outcome timeframe

Chest tube losses are recorded from departure from operating room to chest tube removal in the ICU (normally less than 24 hrs)

Results posted on

2014-07-08

Participant Flow

Began May 1, 2012 Completed January 15, 2013 Patients identified in preadmission clinic or ward.

Exclusion criteria included: renal failure, liver dysfunction, baseline INR \>1.5, clotting factor deficiencies, intra-aortic balloon pump therapy, emergency surgery, pregnancy, ejection fraction less than 50%, age less than 18 years, pulmonary hypertension infectious endocarditis, and history of heparin induced thrombocytopenia.

Participant milestones

Participant milestones
Measure	Heparin Resistant Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.	Heparin Sensitive Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
Overall Study STARTED	29	37
Overall Study COMPLETED	29	37
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Heparin Dose and Post Operative Bleeding in Cardiopulmonary Bypass Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Heparin Resistant n=29 Participants Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.	Heparin Sensitive n=37 Participants Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Age, Continuous	67.4 years STANDARD_DEVIATION 9.8 • n=5 Participants	67.8 years STANDARD_DEVIATION 9.4 • n=7 Participants	67.6 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	32 Participants n=7 Participants	58 Participants n=5 Participants
Region of Enrollment Canada	29 participants n=5 Participants	37 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: Chest tube losses are recorded from departure from operating room to chest tube removal in the ICU (normally less than 24 hrs)

Chest tube losses will be measured in millilitres upon arrival in the Intensive Care unit (ICU) after six hours in the ICU and total chest tube losses during the ICU stay. Chest tube losses are the amount of blood collected in a graduated chest tube collection reservoir from chest tubes placed in the patient's chest wound at the end of surgery.

Outcome measures

Outcome measures
Measure	Heparin Resistant n=29 Participants Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.	Heparin Sensitive n=37 Participants Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
Chest Tube Losses	726 millilters Standard Deviation 371	781 millilters Standard Deviation 320

SECONDARY outcome

Timeframe: Data collection begins with patient arrival in the operating room and ends with discharge from the ICU (normally less than 24hrs)

Transfusion events to recorded will be the number of patients receiving units of red blood cells, units of platelets, units of plasma and units of cryoprecipitate.

Outcome measures

Outcome measures
Measure	Heparin Resistant n=29 Participants Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.	Heparin Sensitive n=37 Participants Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
Transfusion Events	4 Participants Interval 0.02 to 0.58	16 Participants Interval 0.02 to 0.58

Adverse Events

Heparin Resistant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Heparin Sensitive

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark Rosin

Saskatoon Health Region

Phone: 306-655-2128

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place