Biochemical Analysis of Heparins for Injection versus Heparins for Infusion as Prevention of Thrombosis after Bypass Operations

Haemostatic and Fibrinolytic Analysis of Low Molecular Weight Heparin Injections versus Unfractionated Heparin Infusion as Post-CABG Thromboprophylaxis - LITE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000702-19-DK

Enrollment

Unknown

Registered

2015-05-13

Start date

2015-07-22

Completion date

Unknown

Last updated

2017-07-03

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

Conditions

Deep venous thrombosis, myocardial infarction, cerebral infarction, bleeding MedDRA version: 19.0 Level: PT Classification code 10062354 Term: Ischaemic heart disease prophylaxis System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 19.0 Level: LLT Classification code 10023024 Term: Ischaemic heart disease System Organ Class: 100000004849

Interventions

Trade Name: Heparin "LEO" Pharmaceutical Form: Solution for infusion INN or Proposed INN: HEPARIN SODIUM CAS Number: 9041-08-1 Concentration unit: IU/kg international unit(s)/kilogram Concentration ty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients admitted for elective CABG operation at the Thoracical Surgery Deparment at Rigshospitalet. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75

Exclusion criteria

Exclusion criteria: Age < 18 years, reoperations, acute operations (<24 timer), lack of pausation of trombcyte inhibitors 4 days prior to operation, requirement for another trombocyteinhibitor than ASA, weight under 60 kg or above 100 kg, lack of informed conset, treatment with vitamin-K antagonist or NOAC, liver insufficiency, kidney insufficiency, gout, pregnancy, treatment with other anticoagulants, participation in another study, allergy to the IMPs, haemorrhagic diathesis

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this trial is to quantify a possible effect of the change in treatment regimen from ASA to ASA+Clexane on the haemostatic and fibrinolytic system, demonstrated by changes in TEG and Multiplate analyses.;Secondary Objective: Registration of symptomatic trombo-embolic complications og of clinical bleeding episodes within 30 days in the study groups.;Primary end point(s): TEG-analysis: reaction time(R), minutes Multiplate: ASPI test, U ;Timepoint(s) of evaluation of this end point: Blood sample at 9.00 A.M. each postoperative day for 3 days	—

Measure

Time frame

Main Objective: The primary objective of this trial is to quantify a possible effect of the change in treatment regimen from ASA to ASA+Clexane on the haemostatic and fibrinolytic system, demonstrated by changes in TEG and Multiplate analyses.;Secondary Objective: Registration of symptomatic trombo-embolic complications og of clinical bleeding episodes within 30 days in the study groups.;Primary end point(s): TEG-analysis: reaction time(R), minutes Multiplate: ASPI test, U ;Timepoint(s) of evaluation of this end point: Blood sample at 9.00 A.M. each postoperative day for 3 days

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Secondary

Measure	Time frame
Secondary end point(s): Bleeding complications: SAGM-usage, plasma usage, thrombocyte usage, reporeration for bleeding (along with specified cause), GI-bleeding Trombo-embolic complications: CNS injury, AMI, reoperation for AMI Number of patients in each study group experiencing a SUSAR;Timepoint(s) of evaluation of this end point: Noted in case report form during admission and followed up 30 days post operation.	—

Measure

Time frame

Secondary end point(s): Bleeding complications: SAGM-usage, plasma usage, thrombocyte usage, reporeration for bleeding (along with specified cause), GI-bleeding Trombo-embolic complications: CNS injury, AMI, reoperation for AMI Number of patients in each study group experiencing a SUSAR;Timepoint(s) of evaluation of this end point: Noted in case report form during admission and followed up 30 days post operation.

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Countries

Denmark

Contacts

Public ContactRigshospitalet

Rigshospitalet

henrik.arendrup@regionh.dk+4553648609

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026