Recombinant hirudin for cardiopulmonary bypass anticoagulation: a randomized, prospective, and heparin-controlled pilot study.
BACKGROUND
Lepirudin, a recombinant hirudin, is a direct acting thrombin inhibitor that has been used as a heparin alternative in patients with heparin-induced thrombocytopenia requiring on-pump cardiac surgery. To evaluate the efficacy, safety, and clinical utility of lepirudin as a cardiopulmonary bypass (CPB) anticoagulant, we compared lepirudin with heparin in a routine CPB setting.


METHODS
Twenty patients were randomly assigned to receive lepirudin (0.25 mg/kg b. w. bolus and 0.2 mg/kg b. w. added to the CPB priming) or heparin (400 U/kg b. w. bolus) with protamine reversal. Lepirudin and heparin anticoagulation during CPB was monitored using the ecarin clotting time or ACT, respectively and additional lepirudin (5 mg) or heparin (5000 U) boluses were administered.


RESULTS
The CPB circuit was performed in both groups without thromboembolic complications. Median blood loss during the first 36 hours was statistically higher ( P = 0.007) in the lepirudin group (1.226 +/- 316 ml) compared to the heparin group (869 +/- 189 ml). One patient of the lepirudin group developed pulmonary embolism 24 hours after surgery. This patient was tested homozygous for the FV-Leiden mutation.


CONCLUSIONS
Lepirudin provides effective CPB anticoagulation but induces a higher postoperative blood loss than heparin. Lepirudin should be restricted to patients undergoing CPB who cannot be exposed to heparin.
Riess
F-C
FC
Department of Cardiac Surgery, Albertinen Heart Center, Hamburg, Germany. Friedrich-Christian.Riess@albertinen.de
Poetzsch
B
B
Madlener
K
K
Cramer
E
E
Doll
K-N
KN
Doll
S
S
Lorke
D E
DE
Kormann
J
J
Mueller-Berghaus
G
G
D000925:Anticoagulants / Q000627:therapeutic use*; D016063:Blood Loss, Surgical; D002315:Cardiopulmonary Bypass; D001026:Coronary Artery Bypass; D003324:Coronary Artery Disease / Q000601:surgery; D006493:Heparin / Q000627:therapeutic use*; D024764:Hirudin Therapy; D006629:Hirudins / Q000097:blood; D006801:Humans; D007432:Intraoperative Period; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000139:chemically induced; D011994:Recombinant Proteins / Q000097:blood / Q000627:therapeutic use
D000925:Anticoagulants; D006629:Hirudins; D011994:Recombinant Proteins; D006493:Heparin; C083544:lepirudin