Trial Outcomes & Findings for Protamine in Cardiac Surgery and Haemostasis (NCT NCT01608971)

Results Overview

The Intem test of the ROTEM analyzer evaluates the response of the heamostatic system to activation of the intrinsic coagulation system. The following parameters of the INTEM test will be analyzed. CT \[seconds\](coagulation time), CFT \[seconds\] (clot formation time) and the CT \[seconds\] of the HEPTEM test which is non sensitive for residual heparine.

Recruitment status

COMPLETED

Target enrollment

30 participants

Primary outcome timeframe

Tests will be measured 15 minutes after Protamine infusion

Results posted on

2017-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	Heparin Level Based Protamine Group In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.	Weight Based Protamine Group In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Protamine in Cardiac Surgery and Haemostasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Weight Based Protamine Group n=15 Participants In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)	Heparin Level Based Protamine Group n=15 Participants In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.	Total n=30 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	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment Germany	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Tests will be measured 15 minutes after Protamine infusion

Population: Rotem INTEM CT, CFT, MCF and FIBTEM MCF and Heptem CT

The Intem test of the ROTEM analyzer evaluates the response of the heamostatic system to activation of the intrinsic coagulation system. The following parameters of the INTEM test will be analyzed. CT \[seconds\](coagulation time), CFT \[seconds\] (clot formation time) and the CT \[seconds\] of the HEPTEM test which is non sensitive for residual heparine.

Outcome measures

Outcome measures
Measure	Heparin Level Based Protamine Group n=15 Participants In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.	Weight Based Protamine Group n=15 Participants In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
INTEM HEPTEM and FIBTEM Test of the ROTEM Coagulation Analyzer CFT Intem	98 seconds Interval 78.0 to 131.0	117 seconds Interval 103.0 to 170.0
INTEM HEPTEM and FIBTEM Test of the ROTEM Coagulation Analyzer CT Intem	178 seconds Interval 163.0 to 199.0	253 seconds Interval 202.0 to 371.0
INTEM HEPTEM and FIBTEM Test of the ROTEM Coagulation Analyzer CT Heptem	185 seconds Interval 169.0 to 201.0	267 seconds Interval 209.0 to 333.0

PRIMARY outcome

Timeframe: 15 Minutes after protamine infusion

Population: Patients of both groups

The following parameters of the INTEM test will be analyzed: MCF \[mm\] (maximum clot firmness) which correlates with the platelet count. Furthermore, the MCF \[mm\] of the FIBTEM test will be analyzed, which correlates with the fibrinogen concentration.

Outcome measures

Outcome measures
Measure	Heparin Level Based Protamine Group n=15 Participants In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.	Weight Based Protamine Group n=15 Participants In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
Rotem MCF Fibtem and MCF Intem MCF Intem	55 mm Interval 51.0 to 60.0	57 mm Interval 53.0 to 63.0
Rotem MCF Fibtem and MCF Intem MCF Fibtem	9 mm Interval 7.0 to 14.0	13 mm Interval 10.0 to 15.0

SECONDARY outcome

Timeframe: From protamine administration until 12 h after surgery

Population: Transfusion of RBC

The transfusion of blood products and coagulation factors will be assesed from protamine administration until 12 hours postoperatively .

Outcome measures

Outcome measures
Measure	Heparin Level Based Protamine Group n=15 Participants In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.	Weight Based Protamine Group n=15 Participants In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
Transfusion of Blood Products and Coagulation Factors RBC transfusion	76.7 percentage of patients transfused	80 percentage of patients transfused
Transfusion of Blood Products and Coagulation Factors PCC transfusion	20 percentage of patients transfused	60 percentage of patients transfused
Transfusion of Blood Products and Coagulation Factors FFP transfusiom	20 percentage of patients transfused	60 percentage of patients transfused
Transfusion of Blood Products and Coagulation Factors RDPC transfusion	7 percentage of patients transfused	15 percentage of patients transfused
Transfusion of Blood Products and Coagulation Factors Fibrinogen transfusion	33.3 percentage of patients transfused	20 percentage of patients transfused

SECONDARY outcome

Timeframe: 15 min after protamine administration until 12 hours postoperatively

The intra and postoperative blood loss from the time point of protamine administration until 12 hours postoperatively will be analyzed.

Outcome measures

Outcome measures
Measure	Heparin Level Based Protamine Group n=15 Participants In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.	Weight Based Protamine Group n=15 Participants In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
12 h Postoperative Blood Loss	620 ml/12 hour Interval 600.0 to 700.0	723 ml/12 hour Interval 600.0 to 850.0

Adverse Events

Heparin Level Based Protamine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Weight Based Protamine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Heparin Level Based Protamine Group n=15 participants at risk In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.	Weight Based Protamine Group n=15 participants at risk In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
Blood and lymphatic system disorders Excessive bleeding	0.00% 0/15 • 3 months	0.00% 0/15 • 3 months

Other adverse events

Adverse event data not reported

Additional Information

Andreas Koster

Heart and Diabetes Center NRW

Phone: 0043 5731 3284

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place