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The Effect of Heparinization Due to LBW

The Effect of Heparinization Due to LBW in Cardiac Surgery

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03113708
Acronym
LBWH
Enrollment
50
Registered
2017-04-13
Start date
2017-04-30
Completion date
2017-06-20
Last updated
2017-04-14

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

Conditions

Heparin, Heparin Overdose, Bleeding

Keywords

heparin, heparin antagonists, cardiac surgery, active clotting time

Brief summary

High dose heparin regimens are required in cardiac surgery under cardiopulmonary bypass (CPB) and this may increase postoperative bleeding. The aim of this study is to evaluate the effect of heparin dose calculated according to lean body weight on intraoperative and postoperative bleeding.

Detailed description

Patients with preoperative demographic data such as age, gender, body weight, height, and additional disease, medications, previous surgery, preoperative Htc / Hb values were recorded in the operation room without medical premedication. Standard anesthesia induction was performed after arterial cannulation and peripheral venous route. Patients were randomly divided into two groups: 400 IU heparin / kg (Group I) and 400 IU heparin / kg (Group II) according to actual body weight and lean body weight respectively before CPB. Before and after heparin administration, CPB entry and ACT (Activated Clotting Time) values were counted every 30 minutes, after CPB exit and protamine. In both groups, supplemental heparin was administered when there was a failure to reach the pre-CPB target ACT value of 400 sec. Hemodynamic data and transfusion requirements were recorded during the operation. Patient's intraoperative CPB and crossover times, postoperative drainage volume and blood transfusion requirement were recorded.

Interventions

Heparinisation 2-4 mg/kg will be done according to actual body weight or lean body weight.

Sponsors

Adiyaman University Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Caregiver)

Masking description

Closed envelope

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 18-65 years old, first time valve surgeries which was done on-pump.

Exclusion criteria

* Revision valve surgeries * Patients with coagulation deficits

Design outcomes

Primary

MeasureTime frameDescription
ACTThrough study completion, an average of 48 hoursActivated clotting time

Secondary

MeasureTime frameDescription
BleedingThrough study completion, an average of 48 hoursPostoperative bleeding

Contacts

Primary ContactUlku Sabuncu, M.D.
sabuncuulku@gmail.com+90 533 708 5212
Backup ContactAslihan Aykut, M.D.
asli_dncr@hotmail.com+90 532 550 2013

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026