CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01608971
NCT01608971N/ACompleted

The Effects of Heparin Level Based Versus Weight Based Protamine Dosing on Protamine Demand, Markers of Haemostasis, Blood Product Utilization and Perioperative Blood Loss in Patients Undergoing Extended Cardiac Surgery Cardiac Surgery

Heart and Diabetes Center North-Rhine Westfalia·observational·Posted May 31, 2012·Updated Mar 27, 2017

In Brief

An observational study for Bleeding and Hemorrhage. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Protamine is used after Cardiopulmonary Bypass (CPB) to reverse the anticoagulant effects of heparin and restore coagulation. Convincing evidence from in-vitro and in-vivo studies suggest that an overdose of protamine has anticoagulant effects which might lead to bleeding complications. Heparin levels usually decrease during cardiac surgery with CPB. Therefore, a protamine regimen based on the initial heparin dose before CPB might lead to overdose of protamine. In contrast, a protamine regimen based on the actual heparin concentration may avoid this condition. The investigators compare both regimens of protamine dosing in patients undergoing complex surgery with CPB and assess its effect on the amount of protamine given, markers of the coagulation system, utilization of blood products and perioperative blood loss.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBleeding, Hemorrhage
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 31, 2012
Enrollment StartJan 1, 2011
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.1 years ago